Relationship between chemotherapy-induced adverse reactions and health-related quality of life in patients with breast cancer

Rela ionship be ween chemo he apy-induced ad e se eac ions and heal h- ela ed quali y o li e in pa ien s wi h b eas cance Blanca P ie o-Calleje o, PhD a , F ancisco Ri e a, PhD b , Ja ie Fagundo-Ri e a, MSc, MRes c , Adol o Rome o, PhD d , Maca ena Rome o-Ma ín, PhD e , Juan Gómez-Salgado, PhD ,g,∗ , Ca los Ruiz-F u os, PhD ,g Abs ac Backg ound and objec i es: Chemo he apy does no only a ec cance cells; i also a ec s, o a g ea e o lesse deg ee, all o he cells in he body. This oxici y should be assessed acco ding o i s se e i y, equency, and du a ion, aking in o accoun objec i e and subjec i e dimensions in i s assessmen . This assessmen is a highly ele an aspec when p o iding ca e o chemo he apy pa ien s, mainly due o he impac o he ea men on he pa ien ’s quali y o li e, as well as he i al isk i may imply unde ce ain ci cums ances. Fo all his, he objec i e o his s udy was o assess he ela ionship be ween chemo he apy- associa ed ad e se eac ions and heal h- ela ed quali y o li e in b eas cance pa ien s. Ma e ials and me hods: Wi h his pu pose, a desc ip i e c oss-sec ional s udy was de eloped on 110 b eas cance pa ien s who we e ea ed wi h doce axel, epi ubicin, and cyclophosphamide. Resul s: I is wo h highligh ing he nega i e e ec o nausea, dysgeusia, pe iphe al neu opa hy, loss o appe i e, myalgia, and pe iphe al edema on he quali y o li e. Likewise, i is wo h men ioning pe iphe al neu opa hy as he oxici y ha a ec s a g ea e numbe o quali y-o -li e indica o s. Conclusions: To sum up, i would be necessa y o make heal h p o essionals awa e o he impo ance o chemo he apy- associa ed ad e se eac ions. Abb e ia ions: QT =chemo he apy, TEC = ea men scheme consis ing o doce axel, epi ubicin and cyclophosphamide. Keywo ds: b eas cance , d ug- ela ed side e ec s and ad e se eac ions, heal h- ela ed quali y o li e, pa ien sa e y, quali y o heal h ca e, oxici ies 1. In oduc ion Chemo he apy (QT) does no only a ec cance cells; i also a ec s, o a g ea e o lesse deg ee, all o he cells in he body. Specifically, he mos a ec ed cells by he cy o oxic e ec o chemo he apy a e hose ha sha e cha ac e is ics wi h umo cells, especially high-speed cell di ision, such as hai ollicles, bone ma ow, diges i e ac cells, and ep oduc i e sys em cells. The e o e, chemo he apeu ic ea men s ha e a se ies o mo e o less se ious e ec s on he es o he body: These a e called side e ec s o ad e se eac ions. [1] The Wo ld Heal h O ganiza ion defines an Ad e se D ug Reac ion as a esponse o a medicine which is noxious and unin ended, and which occu s a doses no mally used in man o p ophylaxis, diagnosis, o he apy o disease o o he modifica ion o physiologic unc ion. This oxici y should be assessed acco ding o i s se e i y, equency, and du a ion, aking in o accoun objec i e and subjec i e dimensions in i s assessmen . The o me include hose ha can be e alua ed by physical examina ion o labo a o y es s, while he la e would include hose ha cause symp oms ha a e no ela ed o e aluable physical signs o analy ical al e a ions, and hey mus be assessed exclusi ely a he medical consul a ion. The eason o assessing chemo he apy-associa ed oxici y is because many o he ad e se eac ions could be a oided o minimized by pe o ming a ho ough e alua ion a e each chemo he apy cycle. [2,3] The possibili y o a oiding o minimizing Edi o : Vic o C. Kok. The au ho s ha e no conflic s o in e es o disclose. All da a gene a ed o analyzed du ing his s udy a e included in his published a icle [and i s supplemen a y in o ma ion files]. a Hospi al Vi gen de la Bella, Lepe, Huel a, b Depa men o Expe imen al Psychology, Facul y o Psychology, Uni e si y o Se ille, Se ille, c Depa men o Heal h and Eme gencies, Spanish Red C oss, Local Commi ee o Se ille, Doc o al P og amme, Uni e si y o Huel a, Huel a, d Uni e si y Hospi al Vi gen de la Vic o ia, Nu sing and Podia y Depa men , Heal h Sciences School, Uni e si y o Málaga, Málaga, e Nu sing Depa men , Facul y o Nu sing, Uni e si y o Huel a, P e en i e Medicine and Public Heal h Uni , Sociology, Social Wo k and Public Heal h Depa men , Labou Sciences Facul y, Uni e si y o Huel a, Huel a, Spain, g Sa e y and Heal h Pos g adua e P og amme, Uni e sidad Espí i u San o, Guayaquil, Ecuado . ∗ Co espondence: Juan Gómez-Salgado, Depa men o Sociology, Social Wo k and Public Heal h, Uni e si y o Huel a. A enida T es de Ma zo, s/n, Huel a 21007, Spain (e-mail: [email p o ec ed]). Copy igh ©2020 he Au ho (s). Published by Wol e s Kluwe Heal h, Inc. This is an open access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion-Non Comme cial License 4.0 (CCBY-NC), whe e i is pe missible o download, sha e, emix, ans o m, and buildup he wo k p o ided i is p ope ly ci ed. The wo k canno be used comme cially wi hou pe mission om he jou nal. How o ci e his a icle: P ie o-Calleje o B, Ri e a F, Fagundo-Ri e a J, Rome o A, Rome o-Ma ín M, Gómez-Salgado J, Ruiz-F u os C. Rela ionship be ween chemo he apy-induced ad e se eac ions and heal h- ela ed quali y o li e in pa ien s wi h b eas cance . Medicine 2020;99:33(e21695). Recei ed: 11 Ma ch 2020 / Recei ed in final o m: 30 June 2020 / Accep ed: 6 July 2020 h p://dx.doi.o g/10.1097/MD.0000000000021695 Obse a ional S udy Medicine® OPEN 1 Downloaded om h p://jou nals.lww.com/md-jou nal by BhDM 5ePHKa 1zEoum1 Q N4a+kJLhEZgbsIHo4XMi0hCy wCX1AWnYQp/IlQ HD3i3D0OdRyi7T SFl4C 3VC4/OAVpDDa8K2+Ya6H515kE= on 05/16/2023 chemo he apy-associa ed oxici y is a highly ele an aspec in cance pa ien ca e, mainly because o he impac i poses on he pa ien ’s quali y o li e, as well as he i al isk i can cause unde some ci cums ances. [3–6] Oncologis s gene ally main ain, educe, o delay adminis a- ion o he nex chemo he apy cycle based on he collec ed oxici y. [2] Unde es ima ion o ad e se eac ions can lead o lack o dose adjus men s whe e app op ia e and, subsequen ly, he unadjus ed dose may ep oduce o inc ease he complica ions expe ienced in he p e ious cycle, leading o inc eased mo bidi y, a oidable hospi alisa ions, o p ema u e emo al o chemo he apy. [3,4,7,8] In addi ion, pa ien s unde es ima e ad e se eac ions by conside ing hem as pa o he ea men , and e en as a sign ha he ea men is “wo king.” [9–11] The e o e, as Salsman e al [9] demons a e in a desc ip i e compa a i e s udy, al hough pa ien s pe cei e hese ad e se eac ions as disabling, hey o en unde s and hem as a no mal pa o he ea men . Fu he mo e, pa ien s ha e o wai un il hei nex appoin men o epo any oxici y episodes, so incidence and in ensi y a e likely o be subjec ed o memo y biases. On he con a y, physicians s ongly suppo he need o ea hese oxici ies and he ele ance o p o essional abili y o he same pu pose. [9] The esul ing unde - egis a ion o equency and in ensi y con adic s doc o s’belie ha i oxici ies a e a p oblem, hei pa ien s will in o m hem. In gene al, oncology heal h wo ke s o en unde es ima e he incidence o chemo- he apy-associa ed oxici ies. [3,11,12] By con as , he holis ic applica ion o day hospi al nu sing ca e implies a g ea e knowledge o hese ad e se eac ions. [13] Howe e , ad e se eac ions main ained du ing chemo he apy cycles can imply a majo impac on he quali y o li e o he cance pa ien by al e ing me abolic balance, dec easing men al pe o mance, degene a ing sel -ca e and unc ional capaci y, and e en inc easing he isk o wi hd awal o he chemo he apy ea men . [3,10,14,15] In con as , he e a e ew s udies [16] ha link chemo he apy- associa ed oxici ies wi h he pa ien s’quali y o li e. Mos o hem a e ela ed o nausea and omi ing, lymphedema, pain, and symp oms o p ema u e menopause. [16,17] Howe e , hey ba ely collec o he oxici ies, no leas impo an o he pa ien , such as pe iphe al neu opa hy. [18] Fo example, he ea men scheme consis ing o doce axel, epi ubicin, and cyclophosphamide (TEC) has a o able clinical ou comes o b eas cance pa ien s. [19–24] In con as , his scheme is highly oxic o he pa ien ’s body, and i is necessa y o moni o he oxici ies ha occu a e he chemo he apy cycles. [25,26] This con ol would be aimed a educing he dose a he op imal ime o a oid o e dosing. Thus, i is impo an o know, collec , and p o ocolize clinical pe o mance in each o he side e ec s associa ed wi h each ype o chemo he apy d ug. The e o e, he objec i e o his s udy was o analyze he ela ionship be ween chemo he apy-associa ed ad e se eac ions and he heal h- ela ed quali y o li e o b eas cance pa ien s. 2. Me hods 2.1. Design Desc ip i e c oss-sec ional s udy. B eas cance pa ien s in ea men wi h fi s -line neoadju an o adju an chemo he apy wi h doce axel, epi ubicin and cyclophosphamide we e s udied. The o al s udy pe iod was be ween May 2012 and Augus 2014, in a second-le el hospi al (medium le el o complexi y). 2.2. Pa icipan s The inclusion c i e ia implied all b eas cance pa ien s unde chemo he apeu ic ea men , being i neoadju an o adju an , wi h he TEC egimen+filg as im o pegfilg as im colony s imula ing ac o + iple an ieme ic he apy wi h dexame ha- sone, ap epi an , and ondanse on, and who had a leas unde gone 1 cycle h ough his scheme. All pa ien s who, mee ing he inclusion c i e ia, had p e iously esponded o he ques ionnai e de eloped in he s udy, as well as all pa ien s who we e s a ing hei fi s ea men cycle, we e excluded. Fo he calcula ion o he equi ed sample size, he o al numbe o pa ien s wi h hese cha ac e is ics ini ia ing hei ea men o 1 yea h ough he TEC scheme (app oxima ely 60) was aken in o accoun , wi h a ep esen a i e sample size o 52 es ima ed pa ien s, a 95% confidence le el, and a maximum es ima e e o o 5%. Howe e , i was calcula ed ha o es ima e he di e ences in quali y o li e wi h, a leas , an a e age e ec size (Cohen d g ea e han o equal o 0.3), based on a 95% confidence le el, a s a is ical powe o 10%, and an accu acy o 5 poin s, a leas 78 subjec s we e equi ed. Finally, aking in o accoun a low p opo ion o losses in esponses ( ui o a p e iously conduc ed pilo s udy), a minimum sample size o 80 pa ien s was es ablished. The ques ionnai e was gi en andomly, acco ding o a clus e scheme, in 1 o he 6 ea men cycles so, when homogeneously s a ified by he apy cycles, a minimum sample o 10/11 subjec s in each o he cycles was es ima ed. The final sample consis ed o 112 women wi h b eas cance who me he es ablished inclusion c i e ia, hus exceeding he minimum es ablished sample and collec ing, in mos cycles, mo e han he 10/11 p e iously es ablished pa ien s. All he pa ic- ipan s comple ed he 6 chemo he apy cycles. Two pa ien s e en ually declined o pa icipa e in he s udy, so hei da a we e omi ed, and his esul ed in a final sample o 110 pa ien s. 2.3. Ins umen s An “ad hoc”ques ionnai e was p epa ed o he pa ien , including all common nonhema ological ad e se eac ions obse ed wi h he TEC scheme in p e ious clinical ials, [24,27] as well as he specifica ion shee o each d ug, collec ed in he Spanish Agency o Medicines and Medical P oduc s. These oxici ies we e subsequen ly deli e ed, o ex e nal alida ion using a Delphi echnique, o 11 oncologis s ela ed o b eas cance o speci y he es ima ed equency o each oxici y. In addi ion, hey we e asked whe he hey conside ed ha he e was any o he ad e se eac ion o be aken in o accoun . The esul was posi i e o he p epa ed ques ionnai e. To ob ain he e ifica ion o alidi y, he ques ionnai e was subjec ed o p e ious s udy. To his end, he ques ionnai e was p o ided o an ini ial sample o 12 b eas cance pa ien s unde going he TEC scheme and o 5 oncologis s who ea ed b eas cance o assess, on he one hand, he unde s anding o he ques ionnai e and, on he o he hand, he comple eness in he collec ion o he mos common ad e se symp oma ology in his ype o ea men . The esul s showed he adequacy o he ques ionnai e o he p oposed pu poses. P ie o-Calleje o e al. Medicine (2020) 99:33 Medicine 2 Downloaded om h p://jou nals.lww.com/md-jou nal by BhDM 5ePHKa 1zEoum1 Q N4a+kJLhEZgbsIHo4XMi0hCy wCX1AWnYQp/IlQ HD3i3D0OdRyi7T SFl4C 3VC4/OAVpDDa8K2+Ya6H515kE= on 05/16/2023 Fo he assessmen o heal h- ela ed quali y o li e, he Eu oQol-5D ques ionnai e [28] was used o p esen ing an A le el o ecommenda ion and because i bes sui ed he needs o he s udy. Se e al s udies suppo ed he alidi y o he EQ-5D-3L index. [29–31] 2.4. P ocedu e Medical p esc ip ions ha e been e iewed daily by loca ing he pa ien s unde s udy. These pa ien s had o p e-en e he oncology consul a ion and hen go o he Day Hospi al o ecei e hei ea men . A day hospi al is a heal h-cen e ed s uc u e h ough which he pa ien is admi ed o a planned numbe o hou s du ing which hey ecei e specialized ea men om he specialis s. These ea men s equi e moni o ing o medical equipmen ha mus be handled wi hin he medical p emises. A he end o he ca e, he pa ien e u ns home. Then, a he Day Hospi al, each pa ien was gi en he ques ionnai e, ha is, he subjec o s udy, wi h which she esponded o he oxici ies su e ed in he p e ious 21 days, ha is, in he p e ious cycle. The ques ionnai e was gi en andomly in 1 o he 6 ea men cycles. The objec i e and how o app op ia ely answe he ques ions we e explained in de ail. Once comple ed, he pa ien was excluded o he ollowing cycles. In addi ion, he help o nu ses was a ailable a all imes o help wi h any doub s when filling he ques ionnai e. All he pa ien s signed he in o med consen a e ecei ing in o ma ion on i and all he possible doub s had been esol ed by he main esea che . 2.5. Da a analysis Desc ip i e s a is ics, con as es s o p opo ions (x 2 es ) and means (S uden es and Mann–Whi ney U es ), ag eemen le el con as (Cohen Kappa), and e ec size assessmen echniques (Phi, C ame V, and Cohen d) we e used. The s a is ical so wa e used was IBM SPSS S a is ics 22.0 and EQS 6.2. In all cases, a s a is ical significance o P<.05 was equi ed. 2.6. E hical aspec s The s udy was ca ied ou , o he de elopmen and ollow-up o he clinical esea ch, ollowing he “E hical P inciples o Medical Resea ch wi h Humans”compiled in he la es e sion o he Helsinki Decla a ion (Edinbu gh e sion, Oc obe 2000). This s udy was app o ed by he Resea ch E hics Commi ee o he p o ince o Huel a on May 2013, wi h esea ch code: PRI-TEC- 2012-01. In all cases, he anonymi y o he pa icipan s was gua an eed. In addi ion, an in o med w i en consen was ob ained p io o pa icipa ion, and he esea ch p o ocol included he app o al o he Huel a Biomedical Resea ch E hics Commi ee. In addi ion, he basic Law 41/2002 egula ing pa ien au onomy and igh s and obliga ions in he field o in o ma ion and clinical documen a ion was implemen ed. 3. Resul s The final sample consis ed o 110 women. The p ofile o he s udy pa icipan is a woman wi h an a e age age o 49.61 ( ypical de ia ion o 8.28 yea s and wi h a ange o age om 29 o 68 yea s), ma ied (78.9%), wi h child en (83.5%), who is usually accompanied du ing he consul a ion (96.2%). All he pa ien s comple ed he 6 chemo he apy cycles. The ype o ecei ed ea men was ela i ely homogeneous be ween neoadju an (p esu ge y) and adju an (pos su ge y) ea men , wi h esul s o abou 50%. Specifically, he pe cen age o pa ien s who we e ecei ing he ea men as a neoadju an was 44.5%, and 55.5% as adju an . The majo i y o pa ien s esponded o he ques ionnai e o include he ad e se eac ions su e ed a e he 21 days ha las ed hei fi s (26.4%) and second (26.4%) cycle o chemo he apy. The cycle wi h he lowes esponse a e was he fi h one (8.2%), his being he las da a collec ion cycle (Table 1). On he o he hand, 52.3% o pa ien s main ained he same dose as he one p esc ibed a he beginning o he fi s chemo he apy cycle. Howe e , in 47.7% o pa ien s, his dose had o be educed in 20% due o hema ological oxici y (neu openia) o nonhema ological oxici y (pe iphe al neu opa- hy, dia hoea, e c). Specifically, 62.5% o pa ien s s a ed hei second chemo he apy cycle wi h a educed dose. Likewise, 66.4% o pa ien s did no a end an eme gency depa men du ing he whole p ocess. Howe e , 33.6% o hose a ending he eme gency depa men we e e en ually admi ed o hospi al o an a e age o 3 days. 56.7% we e admi ed due o oxici ies su e ed du ing he fi s chemo he apy cycle. As o he ela ionship be ween he quali y o li e and he specific chemo he apy cycle, no significan di e ence was ound (P=.154). Howe e , by analyzing he e ec size, a g ea end is obse ed be ween he quali y o li e in he fi s cycle and he second cycle (Cohen d=0.81). In pa icula , he e is a highe quali y o li e du ing he fi s cycle (mean=15.16) han du ing he second cycle (mean=13.81). In all o he cycles, he e ec size is no significan . Likewise, looking a he di e en indica o s o quali y o li e on he gene al popula ion o he s udy, i is obse ed ha mos pa ien s conside ha hey ha e no p oblems wi h walking (73.4%), sel -ca e (95.4%), e e yday ac i i ies (53.2%) and, in addi ion, hey a e no anxious o dep essed (63.9%). In con as , 56.9% o pa ien s eel mode a e pain o discom o , and 67.9% pe cei e hei o e all heal h wo se han hey did a yea ago. On he o he hand, i is impo an o no e ha 3 pa ien s had o be in bed and 1 pa ien was unable o pe o m daily ac i i ies. In addi ion, 4 pa ien s el a lo o pain o discom o in ha cycle, and 5 pa ien s el e y anxious o dep essed. 3.1. Gas oin es inal oxici y S a is ically significan di e ences ha e been es ablished o he ela ionship nausea-quali y o li e [U (77)=440, P=.020], wi h Table 1 Desc ip ion o he sample in e ms o ea men cha ac e is ics. Numbe o pa ien s % o pa ien s Cycle Fi s cycle 29 26.4% Second cycle 29 26.4% Thi d cycle 19 17.3% Fo h cycle 24 21.8% Fi h cycle 9 8.2% Adju ancy Neoadju ancy 49 44.5% Adju ancy 61 55.5% Dose eadjus men No 59 52.3% Yes 51 47.7% Hospi alisa ion No 74 66.4% Yes 36 33.6% P ie o-Calleje o e al. Medicine (2020) 99:33 www.md-jou nal.com 3 Downloaded om h p://jou nals.lww.com/md-jou nal by BhDM 5ePHKa 1zEoum1 Q N4a+kJLhEZgbsIHo4XMi0hCy wCX1AWnYQp/IlQ HD3i3D0OdRyi7T SFl4C 3VC4/OAVpDDa8K2+Ya6H515kE= on 05/16/2023 an a e age e ec size (Cohen d=0.56). In pa icula , wo se quali y-o -li e indica o s a e obse ed in hose pa ien s who epo ha ing su e ed nausea (mean=13.88), as compa ed wi h hose who do no ha e his symp om (mean=14.88). In addi ion, when analyzing each o he quali y-o -li e componen s, i is obse ed ha pa ien s wi h nausea ha e wo se anxie y o dep ession indica o s [x 2 (2)=7.600, P=.022, C ame V= 0.267]. In pa icula , 54.9% o pa ien s wi h nausea showed no anxie y o dep ession indica o s, as compa ed wi h 80.6% o pa ien s who did no p esen his oxici y (Table 2). As o omi ing, dia hea, cons ipa ion, and mucosi is, no s a is ically significan di e ences ha e been ound in ela ion o he quali y o li e, and he e ec size has been negligible, excep o mucosi is, whe e he e is a small size e ec (Cohen d=0.46). I has no been possible o es ablish i s influence on each o he quali y-o -li e componen s. Table 2 Dis ibu ion o he di e en indica o s o heal h- ela ed quali y o li e based on gas oin es inal oxici y indica o s. Vomi ing Nausea Dia hoea Cons ipa ion No Yes No Yes No Yes No Yes Mobili y I ha e no p oblems walking 73.2% (71) 72.7% (8) 77.8% (28) 70.8% (51) 76.8% (43) 69.8% (37) 71.6% (48) 75.0% (30) I ha e some p oblems walking 23.7% (23) 27.3% (3) 22.2% (8) 25.0% (18) 21.4% (12) 26.4% (14) 25.4% (17) 22.5% (9) I ha e o s ay in bed 3.1% (3) 0.0% (0) 0.0% (0) 4.2% (3) 1.8% (1) 3.8% (2) 3.0% (2) 2.5% (1) Pe sonal ca e I ha e no p oblems wi h pe sonal ca e 95.9% (93) 90,0% (9) 97.2% (35) 94.4% (67) 92.9% (52) 98.1% (51) 93.9% (62) 97.5% (39) I ha e some p oblems washing mysel and ge ing d essed 4.1% (4) 10,0% (1) 2.8% (1) 5.6% (4) 7.1% (4) 1.9% (1) 6.1% (4) 2.5% (1) I canno wash mysel o ge d essed 0.0% (0) 0,0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) Daily ac i i ies I ha e no p oblems pe o ming my daily ac i i ies 53.6% (52) 45,5% (5) 55.6% (20) 51.4% (37) 58.9% (33) 47.2% (25) 50.7% (34) 55.0% (22) I ha e some p oblems pe o ming my daily ac i i ies 45.4% (44) 54,5% (6) 44.4% (16) 47.2% (34) 41.1% (23) 50.9% (27) 47.8% (32) 45.0% (18) I canno pe o m my daily ac i i ies 1.0% (1) 0,0% (0) 0.0% (0) 1.4% (1) 0.0% (0) 1.9% (1) 1.5% (1) 0.0% (0) Pain/discom o I ha e no pain o discom o 42.3% (41) 18,2% (2) 52.8% (19) 33.3% (24) 48.2% (27) 30.2% (16) 38.8% (26) 42.5% (17) I ha e mode a e pain o discom o 54.6% (53) 72,7% (8) 47.2% (17) 61.1% (44) 50.0% (28) 64.2% (34) 56.7% (38) 55.0% (22) I ha e a lo o pain o discom o 3.1% (3) 9,1% (1) 0.0% (0) 5.6% (4) 1.8% (1) 5.7% (3) 4.5% (3) 2.5% (1) Anxie y/dep ession I am no anxious o dep essed 61.9% (60) 80,0% (8) 80.6% (29) 54.9% (39) 69.6% (39) 57.7% (30) 66.7% (44) 57.5% (23) I am mode a ely anxious o dep essed 34.0% (33) 10,0% (1) 19.4% (7) 38.0% (27) 26.8% (15) 36.5% (19) 30.3% (20) 35.0% (14) I am e y anxious o dep essed 4.1% (4) 10,0% (1) 0.0% (0) 7.0% (5) 3.6% (2) 5.8% (3) 3.0% (2) 7.5% (3) Heal h s a us Be e 10.1% (7) 0,0% (0) 8.0% (2) 9.6% (5) 8.3% (3) 9.5% (4) 6.3% (3) 14.3% (4) Same 23.2% (16) 25,0% (2) 36.0% (9) 17.3% (9) 13.9% (5) 31.0% (13) 20.8% (10) 28.6% (8) Wo se 66.7% (46) 75,0% (6) 56.0% (14) 73.1% (38) 77.8% (28) 59.5% (25) 72.9% (35) 57.1% (16) Mucosi is Dysgeusia Loss o appe i e No Yes No Yes No Yes I ha e no p oblems walking 75.8% (47) 69.6% (32) 92.3% (12) 70.8% (68) 80.0% (44) 66.7% (36) Mobili y I ha e some p oblems walking 22.6% (14) 26.1% (12) 7.7% (1) 26.0% (25) 18.2% (10) 29.6% (16) I ha e o s ay in bed 1.6% (1) 4.3% (2) 0.0% (0) 3.1% (3) 1.8% (1) 3.7% (2) I ha e no p oblems wi h pe sonal ca e 96.8% (60) 93.3% (42) 92.3% (12) 95.8% (91) 96.4% (53) 94.3% (50) Pe sonal ca e I ha e some p oblems washing mysel and ge ing d essed 3.2% (2) 6.7% (3) 7.7% (1) 4.2% (4) 3.6% (2) 5.7% (3) I canno wash mysel o ge d essed 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) I ha e no p oblems pe o ming my daily ac i i ies 54.8% (34) 50.0% (23) 76.9% (10) 50.0% (48) 65.5% (36) 40.7% (22) Daily ac i i ies I ha e some p oblems pe o ming my daily ac i i ies 43.5% (27) 50.0% (23) 23.1% (3) 49.0% (47) 34.5% (19) 57.4% (31) I canno pe o m my daily ac i i ies 1.6% (1) 0.0% (0) 0.0% (0) 1.0% (1) 0.0% (0) 1.9% (1) I ha e no pain o discom o 46.8% (29) 30.4% (14) 84.6% (11) 33.3% (32) 49.1% (27) 29.6% (16) Pain/discom o I ha e mode a e pain o discom o 51.6% (32) 63.0% (29) 15.4% (2) 62.5% (60) 50.9% (28) 63.0% (34) I ha e a lo o pain o discom o 1.6% (1) 6.5% (3) 0.0% (0) 4.2% (4) 0.0% (0) 7.4% (4) I am no anxious o dep essed 66.1% (41) 60.0% (27) 84.6% (11) 61.1% (58) 70.9% (39) 56.6% (30) Anxie y / dep ession I am mode a ely anxious o dep essed 33.9% (21) 28.9% (13) 15.4% (2) 33.7% (32) 27.3% (15) 35.8% (19) I am e y anxious o dep essed 0.0% (0) 11.1% (5) 0.0% (0) 5.3% (5) 1.8% (1) 7.5% (4) Be e 10.9% (5) 6.5% (2) 16.7% (1) 8.3% (6) 10.3% (4) 7.7% (3) Heal h s a us Same 23.9% (11) 22.6% (7) 50.0% (3) 20.8% (15) 35.9% (14) 10.3% (4) Wo se 65.2% (30) 71.0% (22) 33.3% (2) 70.8% (51) 53.8% (21) 82.1% (32) In pa en heses: numbe o pa ien s. P ie o-Calleje o e al. Medicine (2020) 99:33 Medicine 4 Downloaded om h p://jou nals.lww.com/md-jou nal by BhDM 5ePHKa 1zEoum1 Q N4a+kJLhEZgbsIHo4XMi0hCy wCX1AWnYQp/IlQ HD3i3D0OdRyi7T SFl4C 3VC4/OAVpDDa8K2+Ya6H515kE= on 05/16/2023 In e ms o loss o appe i e, s a is ically significan di e ences ha e been ound [U (78)=455, P=.002], wi h an a e age e ec size (Cohen d=0.77). In pa icula , wo se quali y-o -li e indica o s a e obse ed in pa ien s who epo loss o appe i e (mean=13.56), as compa ed wi h hose who do no show his p oblem (mean=14.87). Based on he influence on each o he quali y-o -li e componen s, i is obse ed ha pa ien s wi h loss o appe i e ha e wo se indica o s ega ding daily ac i i ies [x 2 (2)=7.251, P=.027, C ame V=0.258], pain o discom o [x 2 (2)=7.386, P=025, C ame V=0.260], and gene al heal h s a us [x 2 (2)= 7.981, P=.018, C ame V=0.320]. Finally, dysgeusia show s a is ically significan di e ences [U (78)=107, P=.038] and a la ge e ec size (Cohen d=0.89). In pa icula , wo se quali y-o -li e ou comes a e shown in pa ien s wi h as e impai men (mean=14.10), as compa ed wi h hose who do no show his al e a ion (mean=15.67). In addi ion, when analyzing each o he quali y-o -li e componen s, i is obse ed ha pa ien s wi h dysgeusia ha e wo se pain o discom o indica o s [x 2 (2)=12.643, P=.002, C ame V=0.341]. 3.2. De ma ological oxici y In e ms o de ma ological oxici ies, no s a is ically significan di e ences in skin eac ion in hands and/o ee and in impai ed nails ha e been ound. In bo h oxici ies, he e ec size has been negligible. Likewise, hese de ma ological oxici ies ha e no shown any s a is ical ela ionship wi h he di e en quali y-o -li e componen s. In con as , ega ding skin alle gies, he e a e s a is ically significan di e ences [U (76)=213, P=.014) and a la ge e ec size (Cohen d=0.88). In pa icula , be e quali y-o -li e indica o s a e shown in pa ien s wi h skin alle gies (mean= 15.50), as compa ed wi h hose who do no e e his symp om (mean=13.95). No di e ences ha e been ound be ween each o he quali y-o -li e componen s. Howe e , by analyzing he e ec size, di e ences can be ound ega ding he gene al heal h s a e [x 2 (2)=5.275, P=.072, C ame V=0.263]. In pa icula , 66.7% o pa ien s wi h skin alle gies show a wo se gene al heal h s a us, as compa ed wi h 67.2% o pa ien s wi hou his oxici y (Table 3). 3.3. Neu ological oxici y Pe iphe al neu opa hy has been con as ed wi h he quali y o li e, finding s a is ically significan di e ences [U (77)=185, P=.000] and also a la ge e ec size (Cohen d=1.34). In pa icula , wo se heal h- ela ed quali y o li e indica o s a e ound in pa ien s who claim o ha e pe iphe al neu opa hy (mean=12.53), as compa ed wi h hose who do no (mean= 14.68). Subsequen ly, as shown in Table 4, i is obse ed ha pa ien s wi h pe iphe al neu opa hy ha e wo se pe sonal ca e indica o s [x 2 (1)=4.608, P=.032, C ame V=0.208], daily ac i i ies [x 2 (2)=9.525, P=.009, C ame V=0.297], pain o discom o [x 2 (2)=11.725, P=0.003, C ame V=0.329], and anxie y o dep ession [x 2 (2)=6.032, P=0.049, C ame V=0.237]. 3.4. Pain- ela ed oxici y As o headaches, abdominal pain, and join pain, no s a is ically significan di e ences ha e been ound, and he e ec size is small. On he o he hand, when analyzing each o he quali y-o - li e componen s, no di e ence can be ound as ega ds he p esence o absence o hese oxici ies. In con as , ega ding abdominal pain, he e a e di e ences as o pain o discom o [x 2 (2)=5.118, P=0.077, C ame V= 0.218] and gene al heal h s a us [x 2 (2)=3.206, P=.201, C ame V=0.204). In e ms o join pain, he e a e di e ences in pain o discom o indica o s [x 2 (2)=15.368, P=.000, C ame V= 0.377]. Table 3 Dis ibu ion o he di e en indica o s o heal h- ela ed quali y o li e based on de ma ological oxici y indica o s. Hands/ ee skin eac ion Nail oxici y Skin alle gies No Yes No Yes No Yes Mobili y I ha e no p oblems walking 70.4% (57) 81.5% (22) 73.0% (54) 73.5% (25) 68.6% (59) 90.5% (19) I ha e some p oblems walking 25.9% (21) 18.5% (5) 24.3% (18) 23.5% (8) 27.9% (24) 9.5% (2) I ha e o s ay in bed 3.7% (3) 0,0% (0) 2.7% (2) 2.9% (1) 3.5% (3) 0.0% (0) Pe sonal ca e I ha e no p oblems wi h pe sonal ca e 95.1% (77) 96.2% (25) 95.9% (70) 94.1% (32) 94.2% (81) 100.0% (20) I ha e some p oblems washing mysel and ge ing d essed 4.9% (4) 3.8% (1) 4.1% (3) 5.9% (2) 5.8% (5) 0.0% (0) I canno wash mysel o ge d essed 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) Daily ac i i ies I ha e no p oblems pe o ming my daily ac i i ies 50.6% (41) 59.3% (16) 59.5% (44) 41.2% (14) 51.2% (44) 61.9% (13) I ha e some p oblems pe o ming my daily ac i i ies 49.4% (40) 37.0% (10) 39.2% (29) 58.8% (20) 47.7% (41) 38.1% (8) I canno pe o m my daily ac i i ies 0.0% (0) 3.7% (1) 1.4% (1) 0.0% (0) 1.2% (1) 0.0% (0) Pain/discom o I ha e no pain o discom o 42.0% (34) 29.6% (8) 44.6% (33) 29.4% (10) 37.2% (32) 47.6% (10) I ha e mode a e pain o discom o 55.6% (45) 63.0% (17) 51.4% (38) 67.6% (23) 58.1% (50) 52.4% (11) I ha e a lo o pain o discom o 2.5% (2) 7.4% (2) 4.1% (3) 2.9% (1) 4.7% (4) 0.0% (0) Anxie y / dep ession I am no anxious o dep essed 63.0% (51) 65.4% (17) 65.8% (48) 61.8% (21) 59.3% (51) 80.0% (16) I am mode a ely anxious o dep essed 33.3% (27) 26.9% (7) 28.8% (21) 35.3% (12) 34.9% (30) 20.0% (4) I am e y anxious o dep essed 3.7% (3) 7.7% (2) 5.5% (4) 2.9% (1) 5.8% (5) 0.0% (0) Heal h s a us Be e 8.6% (5) 10.5% (2) 12.7% (7) 0.0% (0) 6.3% (4) 25.0% (3) Same 24.1% (14) 21.1% (4) 21.8% (12) 27.3% (6) 26.6% (17) 8.3% (1) Wo se 67.2% (39) 68.4% (13) 65.5% (36) 72.7% (16) 67.2% (43) 66.7% (8) In pa en heses: numbe o pa ien s. P ie o-Calleje o e al. Medicine (2020) 99:33 www.md-jou nal.com 5 Downloaded om h p://jou nals.lww.com/md-jou nal by BhDM 5ePHKa 1zEoum1 Q N4a+kJLhEZgbsIHo4XMi0hCy wCX1AWnYQp/IlQ HD3i3D0OdRyi7T SFl4C 3VC4/OAVpDDa8K2+Ya6H515kE= on 05/16/2023 As o muscle pain, s a is ically significan di e ences ha e been ound [U (77)=436, P=.003], and he e ec size is mode a e (Cohen d=0.76). In pa icula , wo se quali y-o -li e indica o s a e ound in hose pa ien s wi h myalgia (mean=13.6, 9), as compa ed wi h hose who do no show his symp om (mean=15.00). Then, when analyzing each o he quali y-o -li e componen s, i is obse ed ha pa ien s wi h myalgia ha e wo se pain o discom o [x 2 (2)=16.166, P=.000, C ame V=0.387] and gene al heal h s a us indica o s [x 2 (2)=7.831, P=.020, C ame V=0.319) (Table 5). 3.5. Eye oxici y Rega ding conjunc i i is, no s a is ically significan di e ences ha e been ound, bu an app op ia e, al hough small, e ec size is shown (Cohen d=0.35). Rega ding his oxici y, wo se quali y- o -li e indica o s a e obse ed in pa ien s wi h he conjunc i i is (mean=13.83), as compa ed wi h hose who do no show his symp om (mean=14.46). By analyzing each o he quali y-o -li e componen s, no s a is ically significan di e ence has been ound be ween hem. Howe e , by analyzing he e ec size, di e ences in he gene al heal h s a us a e ound [x 2 (2)=3.337, P=.189, C ame V= 0.207]. In pa icula , 80.0% o pa ien s wi h conjunc i i is a e hei gene al heal h s a us as wo se, as compa ed wi h 60.4% o pa ien s who do no ha e his eye oxici y (Table 6). 3.6. Cons i u ional symp oms The p esence o as henia has hen been con as ed wi h he quali y o li e, whe e no s a is ically significan di e ences ha e been ound and he e ec size has been mode a e (Cohen d= 0.64). In pa icula , wo se quali y-o -li e indica o s a e ound in hose pa ien s who e e as henia (mean=14.09), as compa ed wi h hose who do no show his oxici y (mean=15.25). On he o he hand, when analyzing each o he quali y-o -li e componen s, i is obse ed ha pa ien s wi h as henia ha e wo se mobili y [x 2 (2)=11.442, P=.003, C ame V=0.325], daily ac i i ies [x 2 (2)=6.137, P=.046, C ame =0.238), and pain o discom o indica o s [x 2 (2)=6.762, P=.034, C ame V=.250] (Table 7). 3.7. Lympha ic sys em oxici y In e ms o oxici y a ec ing he lympha ic sys em, pe iphe al edema, s a is ically significan di e ences, and a la ge e ec size ha e been ound (Cohen d=0.88). In pa icula , pa ien s wi h pe iphe al edema (mean=13.20) show wo se quali y-o -li e indica o s han hose wi hou his oxici y (mean=14.69). Then, when analyzing each o he quali y-o -li e componen s, i is obse ed ha pa ien s wi h pe iphe al edema ha e wo se mobili y [x 2 (2)=19.875, P=.000, C ame V=0.429], pain o discom o [x 2 (2)=9.875, P=.007, C ame V=0.302], and gene al heal h s a us indica o s [x 2 (2)=7.096, P=029, C ame V=0.304] (Table 8). Co ela ions be ween ad e se eac ions and heal h- ela ed quali y o li e a e summa ized in Table 9. 4. Discussion Chemo he apy ea men s a e ela ed o majo oxici ies ha mus be closely moni o ed by he doc o a each o he pa ien ’s consul a ions, p io o he adminis a ion o he nex chemo- he apy cycle, in a simila way o he collec ion o oxici ies in he con ex o a clinical ial. Howe e , in s anda d clinical p ac ice, he pa ien ’s assump ion ha oxici ies a e una oidable and in insic o he ea men makes he collec ion o nonhema o- logical ad e se eac ions incomple e. Meanwhile, as P ies man and Baum [28] demons a ed in 1976, he influence o ad e se eac ions on he quali y o li e o cance pa ien s is highly ele an . The e a e s udies [32] ha show ha low quali y o li e nega i ely p edisposes o he onse o ce ain diseases, including b eas cance . The e o e, i can be concluded Table 4 Dis ibu ion o he di e en indica o s o heal h- ela ed quali y o li e based on neu ological oxici y indica o s. Pe iphe al neu opa hy No Yes Mobili y I ha e no p oblems walking 76.2% (64) 62.5% (15) I ha e some p oblems walking 21.4% (18) 33.3% (8) I ha e o s ay in bed 2.4% (2) 4.2% (1) Pe sonal ca e I ha e no p oblems wi h pe sonal ca e 97.6% (82) 87.0% (20) I ha e some p oblems washing mysel and ge ing d essed 2.4% (2) 13.0% (3) I canno wash mysel o ge d essed 0.0% (0) 0.0% (0) Daily ac i i ies I ha e no p oblems pe o ming my daily ac i i ies 59.5% (50) 29.2% (7) I ha e some p oblems pe o ming my daily ac i i ies 40.5% (34) 66.7% (16) I canno pe o m my daily ac i i ies 0.0% (0) 4.2% (1) Pain/discom o I ha e no pain o discom o 46.4% (39) 16.7% (14) I ha e mode a e pain o discom o 52.4% (44) 70.8% (17) I ha e a lo o pain o discom o 1.2% (1) 12.5% (3) Anxie y/dep ession I am no anxious o dep essed 67.9% (57) 47.8% (11) I am mode a ely anxious o dep essed 29.8% (25) 39.1% (9) I am e y anxious o dep essed 2.4% (2) 13.0% (3) Heal h s a us Be e 10.0% (6) 5.9% (1) Same 28.3% (17) Wo se 61.7% (3) 88.2% (15) In pa en heses: numbe o pa ien s. P ie o-Calleje o e al. Medicine (2020) 99:33 Medicine 6 Downloaded om h p://jou nals.lww.com/md-jou nal by BhDM 5ePHKa 1zEoum1 Q N4a+kJLhEZgbsIHo4XMi0hCy wCX1AWnYQp/IlQ HD3i3D0OdRyi7T SFl4C 3VC4/OAVpDDa8K2+Ya6H515kE= on 05/16/2023 ha a poo es quali y o li e has a nega i e impac on add essing he ea men p ocess. The esul s o his s udy highligh he nega i e impac o oxici ies such as nausea, dysgeusia, pe iphe al neu opa hy, loss o appe i e, myalgia, and pe iphe al edema on b eas cance pa ien s’quali y o li e. As Ga cía-Luna e al [33] show, nausea, dysgeusia, and loss o appe i e induce he onse o malnu i ion in he cance pa ien . This leads o a dec ease in muscle mass and, he e o e, a o s o e all weakness o he pa ien . I s impac implies, in addi ion o dec easing quali y o li e (da a Table 6 Dis ibu ion o he di e en indica o s o heal h- ela ed quali y o li e based on eye oxici y indica o s. Conjunc i i is No Yes Mobili y I ha e no p oblems walking 78.8% (52) 65.1% (28) I ha e some p oblems walking 18.2% (12) 32.6% (14) I ha e o s ay in bed 3.0% (2) 2.3% (1) Pe sonal ca e I ha e no p oblems wi h pe sonal ca e 95.5% (63) 95.2% (40) I ha e some p oblems washing mysel and ge ing d essed 4.5% (3) 4.8% (2) I canno wash mysel o ge d essed 0.0% (0) 0.0% (0) Daily ac i i ies I ha e no p oblems pe o ming my daily ac i i ies 54.5% (36) 51.2% (22) I ha e some p oblems pe o ming my daily ac i i ies 45.5% (30) 46.5% (20) I canno pe o m my daily ac i i ies 0.0% (0) 2.3% (1) Pain/discom o I ha e no pain o discom o 43.9% (29) 32.6% (14) I ha e mode a e pain o discom o 53.0% (35) 62.8% (27) I ha e a lo o pain o discom o 3.0% (2) 4.7% (2) Anxie y/dep ession I am no anxious o dep essed 62.1% (41) 66.7% (28) I am mode a ely anxious o dep essed 33.3% (22) 28.6% (12) I am e y anxious o dep essed 4.5% (3) 4.8% (2) Heal h s a us Be e 10.4% (5) 6.7% (2) Same 29.2% (14) 13.3% (4) Wo se 60.4% (29) 80.0% (24) In pa en heses: numbe o pa ien s. Table 5 Dis ibu ion o he di e en indica o s o heal h- ela ed quali y o li e based on pain- ela ed oxici y indica o s. Headache Abdominal pain Join pain Muscle pain No Yes No Yes No Yes No Yes Mobili y I ha e no p oblems walking 68.0% (34) 77.6% (45) 72.7% (48) 73.8% (31) 80.5% (33) 68.7% (46) 80.0% (36) 69.8% (44) I ha e some p oblems walking 30.0% (15) 19.0% (11) 24.2% (16) 23.8% (10) 17.1% (7) 28.4% (19) 17.8% (8) 27.0% (17) I ha e o s ay in bed 2.0% (1) 3.4% (2) 3.0% (2) 2.4% (1) 2.4% (1) 3.0% (2) 2.2% (1) 3.2% (2) Pe sonal ca e I ha e no p oblems wi h pe sonal ca e 98.0% (49) 93.0% (53) 95.5% (63) 95.1% (39) 97.6% (40) 93.9% (62) 95.6% (43) 95.2% (59) I ha e some p oblems washing mysel and ge ing d essed 2.0% (1) 7.0% (4) 4.5% (3) 4.9% (2) 2.4% (1) 6.1% (4) 4.4% (2) 4.8% (3) I canno wash mysel o ge d essed 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0) Daily ac i i ies I ha e no p oblems pe o ming my daily ac i i ies 50.0% (25) 55.2% (32) 59.1% (39) 42.9% (18) 58.5% (24) 49.3% (33) 64.4% (29) 46.0% (29) I ha e some p oblems pe o ming my daily ac i i ies 50.0% (25) 43.1% (25) 40.9% (27) 54.8% (23) 41.5% (17) 49.3% (33) 35.6% (16) 52.4% (33) I canno pe o m my daily ac i i ies 0.0% (0) 1.7% (1) 0.0% (0) 2.4% (1) 0.0% (0) 1.5% (1) 0.0% (0) 1.6% (1) Pain/discom o I ha e no pain o discom o 48.0% (24) 32.8% (19) 47.0% (31) 28.6% (12) 63.4% (26) 25.4% (17) 62.2% (28) 23.8% (15) I ha e mode a e pain o discom o 48.0% (24) 63.8% (37) 51.5% (34) 64.3% (27) 34.1% (14) 70.1% (47) 35.6% (16) 71.4% (45) I ha e a lo o pain o discom o 4.0% (2) 3.4% (2) 1.5% (1) 7.1% (3) 2.4% (1) 4.5% (3) 2.2% (1) 4.8% (3) Anxie y/dep ession I am no anxious o dep essed 66.0% (33) 61.4% (35) 72.7% (48) 48.8% (20) 61.0% (25) 65.2% (43) 68.9% (31) 59.7% (37) I am mode a ely anxious o dep essed 30.0% (15) 33.3% (19) 22.7% (15) 46.3% (19) 36.6% (15) 28.8% (19) 26.7% (12) 35.5% (22) I am e y anxious o dep essed 4.0% (2) 5.3% (3) 4.5% (3) 4.9% (2) 2.4% (1) 6.1% (4) 4.4% (2) 4.8% (3) Heal h s a us Be e 10.8% (4) 7.5% (3) 8.7% (4) 9.7% (3) 12.0% (3) 7.7% (4) 18.8% (6) 2.2% (1) Same 29.7% (11) 17.5% (7) 30.4% (14) 12.9% (4) 24.0% (6) 23.1% (12) 28.1% (9) 20.0% (9) Wo se 59.5% (22) 75.0% (30) 60.9% (28) 77.4% (24) 64.0% (16) 69.2% (36) 53.1% (17) 77.8% (35) In pa en heses: numbe o pa ien s. P ie o-Calleje o e al. Medicine (2020) 99:33 www.md-jou nal.com 7 Downloaded om h p://jou nals.lww.com/md-jou nal by BhDM 5ePHKa 1zEoum1 Q N4a+kJLhEZgbsIHo4XMi0hCy wCX1AWnYQp/IlQ HD3i3D0OdRyi7T SFl4C 3VC4/OAVpDDa8K2+Ya6H515kE= on 05/16/2023 co obo a ed in his s udy), an inc ease in dependence on ca e by amily membe s o ca egi e s and an inc eased s a e o immunosupp ession, which is associa ed wi h he isk o in ec ious complica ions. I is easonable o conclude ha all o his will psychologically a ec he cance pa ien . Fu he mo e, i is no ewo hy ha 89.9% o pa ien s deny ha ing su e ed an episode o omi ing and ha 75.2% o hem ha e no su e ed pe iphe al edema du ing he las 21 days. Howe e , omi ing is commonly epo ed as associa ed wi h hese chemo he apy ea men s. [9] The low incidence o omi ing e e ed o in his s udy may be due o he high e ficacy o he used p ophylac ic an ieme ic: ap epi an . [34,35] Howe e , ea men wi h ap epi an does no educe nausea, some hing ha is confi med by 67.0% o pa ien s in his s udy who claim o ha e su e ed i . Likewise, he p ophylac ic use o co icos e oids may be associa ed wi h he low pe cen age o pe iphe al edema epo ed. In addi ion, o he oxici ies such as mucosi is, headache, abdominal pain, a h algia, conjunc i i is, and as henia showed a nega i e end on he pa ien s’quali y o li e, so i could be expec ed ha , by inc easing he sample size, his end would become clea e and s a is ically significan . Likewise, his s udy demons a es he nega i e implica ion o he di e en oxici ies on each o he heal h- ela ed quali y-o -li e Table 8 Dis ibu ion o he di e en indica o s o heal h- ela ed quali y o li e based on lympha ic sys em oxici y indica o s. Pe iphe al edema No Yes Mobili y I ha e no p oblems walking 82.7% (67) 44.4% (12) I ha e some p oblems walking 13.6% (11) 55.6% (15) I ha e o s ay in bed 3.7% (3) 0.0% (0) Pe sonal ca e I ha e no p oblems wi h pe sonal ca e 97.5% (79) 88.5% (23) I ha e some p oblems washing mysel and ge ing d essed 2.5% (2) 11.5% (3) I canno wash mysel o ge d essed 0.0% (0) 0.0% (0) Daily ac i i ies I ha e no p oblems pe o ming my daily ac i i ies 58.0% (47) 37.0% (10) I ha e some p oblems pe o ming my daily ac i i ies 42.0% (34) 59.3% (16) I canno pe o m my daily ac i i ies 0.0% (0) 3.7% (1) Pain/discom o I ha e no pain o discom o 48.1% (39) 14.8% (4) I ha e mode a e pain o discom o 49.4% (40) 77.8% (21) I ha e a lo o pain o discom o 2.5% (2) 7.4% (2) Anxie y/dep ession I am no anxious o dep essed 69.1% (56) 46.2% (12) I am mode a ely anxious o dep essed 25.9% (21) 50.0% (13) I am e y anxious o dep essed 4.9% (4) 3.8% (1) Heal h s a us Be e 11.5% (6) 4.0% (1) Same 30.8% (16) 8.0% (2) Wo se 57.7% (30) 88.0% (22) In pa en heses: numbe o pa ien s. Table 7 Dis ibu ion o he di e en indica o s o heal h- ela ed quali y o li e based on cons i u ional symp om indica o s. As henia No Yes Mobili y I ha e no p oblems walking 87.5% (14) 70.7% (65) I ha e some p oblems walking 0.0% (0) 28.3% (26) I ha e o s ay in bed 12.5% (2) 1.1% (1) Pe sonal ca e I ha e no p oblems wi h pe sonal ca e 100.0% (13) 94.5% (86) I ha e some p oblems washing mysel and ge ing d essed 0.0% (0) 5.5% (5) I canno wash mysel o ge d essed 0.0% (0) 0.0% (0) Daily ac i i ies I ha e no p oblems pe o ming my daily ac i i ies 81.3% (13) 47.8% (44) I ha e some p oblems pe o ming my daily ac i i ies 18.8% (3) 51.1% (47) I canno pe o m my daily ac i i ies 0.0% (0) 1.1% (1) Pain/discom o I ha e no pain o discom o 68.8% (11) 34.8% (32) I ha e mode a e pain o discom o 31.3% (5) 60.9% (56) I ha e a lo o pain o discom o 0.0% (0) 4.3% (4) Anxie y/dep ession I am no anxious o dep essed 75.0% (12) 61.5% (56) I am mode a ely anxious o dep essed 25.0% (4) 33.0% (30) I am e y anxious o dep essed 0.0% (0) 5.5% (5) Heal h s a us Be e 0.0% (0) 10.1% (7) Same 37.5% (3) 21.7% (15) Wo se 62.5% (5) 68.1% (47) In pa en heses: numbe o pa ien s. P ie o-Calleje o e al. Medicine (2020) 99:33 Medicine 8 Downloaded om h p://jou nals.lww.com/md-jou nal by BhDM 5ePHKa 1zEoum1 Q N4a+kJLhEZgbsIHo4XMi0hCy wCX1AWnYQp/IlQ HD3i3D0OdRyi7T SFl4C 3VC4/OAVpDDa8K2+Ya6H515kE= on 05/16/2023 indica o s. Focusing on each o he quali y-o -li e a iables, he e a e di e ences in he in ol emen o ce ain oxici ies in he di e en componen s. On he one hand, he anxie y o dep ession indica o emains a ec ed by nausea, mucosi is, pe iphe al neu opa hy, and abdominal pain. As ega ds pain o discom o , 7 oxici ies would be in ol ed: loss o appe i e, dysgeusia, pe iphe al neu opa hy, a h algia, myalgia, as henia, and pe iphe al edema. Daily ac i i ies a e influenced by loss o appe i e, pe iphe al neu opa hy, and as henia. This las oxici y also has an impac on he mobili y indica o , in addi ion o pe iphe al edema. Pe sonal ca e is only a ec ed by pe iphe al neu opa hy. In he case o pe iphe al neu opa hy and pe iphe al edema, i is no ewo hy ha despi e ob aining a below 25% pe cen age o p esence in he s udy pa ien s, hese a e oxici ies ha significan ly a ec quali y o li e. This may be due o he lack o alidi y o all he symp oms associa ed wi h hese a iables. [6] Pe iphe al neu opa hy is also wo h no ing because i is he oxici y ha a ec s a g ea e numbe o quali y-o -li e indica o s (anxie y o dep ession, pain o discom o , daily ac i i ies, and pe sonal ca e). This may be due o he se e i y o his oxici y as i a ec s he whole o ganism, om deep pain ollowed by numbness, mainly in he hands and ee , muscle in ol emen wi h a eeling o weakness, as well as p oblems wi h diges ing, sexual ela ionships, hea in ol emen , and mo e. Beus e ien e al [18] demons a ed in hei s udy ha b eas cance pa ien s p io i ized ce ain side e ec s, such as pe iphe al neu opa hy, o e o he s, such as alopecia, which hey conside ed mino . They e en claimed o be willing o accep a less con enien chemo he apy ea men scheme o a oid an inc eased isk o side e ec s such as pe iphe al neu opa hy. In sho , despi e he ad ances in he con ol o symp oms associa ed wi h chemo he apy ea men s, he pa ien ’s pe cep- ion is s ill a pending ask o all heal h wo ke s. These mus be awa e o he impo ance o knowing he pa ien and hus a oiding hospi al admissions, delays in chemo he apy cycles, o e en suspension o he cycles as a esul o accumula ed oxici y. [11,14] As o he limi a ions o his s udy, as a 1-cen e s udy, he e is a possibili y ha he s udy popula ion will be subjec ed o ce ain common bias. In addi ion, he ques ionnai e was ca ied ou andomly in a specific cycle o he 6 co esponding o he comple e ea men o he pa ien , so he e is a possibili y ha he s udied cycle was no he one in which he pa ien p esen ed a highe numbe o oxici ies. Simila ly, as an obse a ional design, causal ela ionships canno be es ablished, and we can only alk o co ela ions be ween he a iables. The e o e, u he s udies wi h a la ge sample size would be needed o co obo a e he esul s and conclusions o his s udy. In gene al, quali y-o -li e esul s highligh he need o imp o e he assessmen o he e ec s o he ea men on he pa ien s’ quali y o li e. This could be he goal o de eloping a sel - efillable ques ionnai e ega ding he pa ien s’pe cep ion o hei own heal h s a us and symp oms o ob ain mo e in o ma ion and mo e de ailed da a on hese issues h ough pa ien sel - assessmen . Pa ien s could b ing his sel -assessmen home o ha e a digi al eco d a ailable wi h he aim o ob aining mo e comple e da a on he ad e se eac ions su e ed du ing he 21 days he pa ien is a home. In his line, he e a e s udies [9,34] ha ha e analyzed he pe cei ed quali y o li e o pa ien s as compa ed wi h he usual p ac ice, which show ha quali y o li e is a ec ed by he ca e ecei ed in hospi als du ing he pa ien ’s illness, hus highligh ing he lack o in o ma ion ha heal h p o essionals ha e abou pa ien s’pe cep ions. The impo ance o in oducing a mul idisciplina y eam aimed a imp o ing he accep ance o chemo he apy in hese pa ien s has been demons a ed in a coho s udy conduc ed among 13,722 b eas cance pa ien s. [36] This is why his could be a line o imp o emen in eal ca e o hese ypes o cance pa ien s. On he o he hand, i would be necessa y o aise awa eness among heal hca e p o essionals o he impo ance o ad e se eac ions in chemo he apeu ic ea men s. Cance pa ien s may eel mo e welcomed by he heal h sys em and mo e pa icipa i e in e e y hing ha a ec s he e olu ion o hei ea men and disease. [11] In conclusion, he p esence o ad e se eac ions ela ed o he TEC ea men scheme significan ly dec eases heal h- ela ed quali y o li e. In pa icula , nausea, loss o appe i e, dysgeusia, pe iphe al neu opa hy, myalgia, and pe iphe al edema a e hose oxici ies whe e his di e ence has been significan . Au ho con ibu ions Concep ualiza ion: Blanca P ie o-Calleje o. Da a cu a ion: Blanca P ie o-Calleje o, F ancisco Ri e a. Fo mal analysis: Blanca P ie o-Calleje o, F ancisco Ri e a, Adol o Rome o, Maca ena Rome o-Ma ín. In es iga ion: Blanca P ie o-Calleje o, Adol o Rome o, Ca los Ruiz-F u os. Me hodology: F ancisco Ri e a, Ja ie Fagundo-Ri e a, Adol o Rome o, Maca ena Rome o-Ma ín, Juan Gómez-Salgado, Ca los Ruiz-F u os. P ojec adminis a ion: Blanca P ie o-Calleje o. Resou ces: F ancisco Ri e a, Ja ie Fagundo-Ri e a, Juan Gómez-Salgado, Ca los Ruiz-F u os. So wa e: F ancisco Ri e a, Ja ie Fagundo-Ri e a. Supe ision: Adol o Rome o, Juan Gómez-Salgado. Valida ion: F ancisco Ri e a, Adol o Rome o. Table 9 Co ela ion be ween ad e se eac ions and heal h- ela ed quali y o li e. Ad e se eac ion Mann–Whi ney U es PCohen d Vomi ing 267 (77) .879 0.13 Nausea 440 (77) .020 ∗ 0.56 Dia hea 746 (78) .923 0.03 Cons ipa ion 613 (76) .522 0.17 Mucosi is 548 (77) .081 0.46 Loss o appe i e 455 (78) .002 ∗ 0.77 Dysgeusia 107 (78) .038 ∗ 0.89 Skin eac ion in hands and/o ee 510 (77) .626 0.09 Impai ed nails 564 (77) .642 0.14 Skin alle gies 213 (76) .014 0.88 Pe iphe al neu opa hy 185 (77) .000 ∗ 1.34 Myalgia 628 (77) .248 0.30 Abdominal pain 559 (77) .104 0.37 Join pain 502 (77) .103 0.39 Muscle pain 436 (77) .003 ∗ 0.76 Conjunc i i is 581 (78) .148 0.35 As henia 168 (77) .068 0.64 Pe iphe al edema 337 (77) .001 ∗ 0.88 ∗ S a is ically significan . P ie o-Calleje o e al. 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