Sensor-controlled scalp cooling to prevent chemotherapy-induced alopecia in female cancer patients

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1 ORIGINAL ARTICLE Sensor-controlled sclp cooling to prevent chemotherpy-induced lopeci in femle cncer ptients M.K. Fehr md,* J. Welter mph,* W. Sell md,* R. Jung,* nd R. Felberbum md ABSTRACT Bckground Sclp cooling hs been used since the 1970s to prevent chemotherpy-induced lopeci, one of the most common nd psychologiclly troubling side effects of chemotherpy. Currently vilble sclp cooling systems demonstrte vrying results in terms of effectiveness nd tolerbility. Methods For the present prospective study, 55 women receiving neodjuvnt, djuvnt, or pllitive chemotherpy were enrolled. The im ws to ssess the effectiveness of sensor-controlled sclp cooling system (DigniCp: Sysmex Europe GmbH, Norderstedt, Germny) to prevent chemotherpy-induced lopeci in brest or gynecologic cncer ptients receiving 1 of 7 regimens. Clinicl ssessments, stisfction questionnires, nd lopeci evlutions [World Helth Orgniztion (who) grding for toxicity] were completed t bseline, t ech cycle, nd t completion of chemotherpy. Results Of the 55 ptients, 78% underwent sclp cooling until completion of chemotherpy. In multivrite nlysis, younger women nd those receiving pclitxel weekly or pclitxel crbopltin experienced less lopeci. The compound successful outcome ( no hed covering plus who grde 0/1 ) ws observed in ll ptients 50 yers of ge nd younger receiving 4 cycles of docetxel cyclophosphmide or 6 cycles of pclitxel crbopltin. Conversely, lopeci ws experienced by ll women receiving triplet polychemotherpy (6 cycles of docetxel doxorubicin cyclophosphmide). For women receiving sequentil polychemotherpy regimens (3 cycles of fluorourcil epirubicin cyclophosphmide followed by 3 cycles of docetxel or 4 cycles of doxorubicin cyclophosphmide followed by 4 cycles of docetxel), the subgroup 50 yers of ge nd younger experienced 43% success rte compred with 10% rte for the subgroup pf older women receiving the sme regimens. Conclusions The bility of sclp cooling to prevent chemotherpy-induced lopeci vries with the chemotherpy regimen nd the ge of the ptient. Use of compound endpoint with subjective nd objective mesures provides insightful nd prcticl informtion when counselling ptients. Key Words Chemotherpy-induced lopeci, sensor-controlled sclp cooling, brest cncer, ovrin cncer Curr Oncol Dec;23(6):e576-e582 INTRODUCTION Sclp cooling hs been used for pproximtely 40 yers to prevent chemotherpy-induced hir loss 1. Temporry chemotherpy-induced lopeci, one of the most common nd distressing side effects of chemotherpy tretment, cn led to negtive body imge, lower self-esteem, sexul impirment, severe depression, nxiety, nd disturbnces in socil reltionships 2. Fer of hir loss nd the ssocited distress cn even result in refusl to undergo pproprite chemotherpy tretment 3. The precise mechnism for mitigting lopeci remins uncler, nd the sclp cooling systems currently on the mrket demonstrte vrying results in terms of effectiveness nd tolerbility for the ptients 4. The potentil risk of sclp cooling lies in the protection of sclp metstsis from the effects of chemotherpy. However, tht potentil risk hs, to dte, been proved in only 2 ptients 5. Both of those ptients hd hemtologic mlignncies which, bsed on the published report, re regrded s contrindiction to sclp cooling. The im of our study ws to ssess the effectiveness nd tolerbility of feedbck-controlled sclp cooling Correspondence to: Mthis K. Fehr, Deprtment of Obstetrics nd Gynecology, Cntonl Hospitl Fruenfeld, CH-8501 Fruenfeld, Switzerlnd. E-mil: mthis.fehr@stgg.ch n DOI: e576

2 system regulted by direct mesurement of the ptient s individul sclp temperture (DigniCp sclp cooling system: Sysmex Europe GmbH, Norderstedt, Germny) with respect to preventing chemotherpy-induced lopeci in brest or gynecologic cncer ptients receiving 1 of 7 chemotherpy regimens. METHODS For this prospective cohort study, 55 femle ptients were recruited from two cncer tretment centres in Germny nd Switzerlnd strting in 2013 to the end of The study ws pproved by the corresponding ethics commission (reference no ). All consecutive cncer ptients 18 yers of ge nd older who plnned to undergo neodjuvnt or djuvnt chemotherpy for brest, endometril, or ovrin cncer were ssessed for enrolment in the study. A ptient ws not eligible if she hd grde 2 or greter hir loss t the bseline ssessment or if she ws unwilling to extend the durtion of the required stndrd chemotherpy for the pre- nd post-tretment sclp cooling process. Of the 68 women ssessed for inclusion in the study, 55 were eligible nd gve written consent to be enrolled. The types of chemotherpy received by the ptients were these: Pclitxel 175 mg/m 2 nd crbopltin 6 uc (re under the curve) for 6 three-week cycles [n = 12 (22%)] Doxorubicin 60 mg/m 2 nd cyclophosphmide 600 mg/ m 2 for 4 three-week cycles, followed by docetxel 100 mg/m 2 for 4 three-week cycles [n = 11 (20%)] Epirubicin 90 mg/m 2 nd cyclophosphmide 600 mg/ m 2 for 4 three-week cycles, followed by pclitxel 80 mg/m 2 weekly for 12 weeks [n = 10 (18%)] Pclitxel 80 mg/m 2 weekly for 16 weeks [n = 8 (15%)] Docetxel 75 mg/m 2 nd cyclophosphmide 500 mg/ m 2 for 4 three-week cycles [n = 6 (11%)] Fluorourcil 500 mg/m 2, epirubicin 100 mg/m 2, nd cyclophosphmide 500 mg/m 2 for 3 three-week cycles, followed by docetxel 100 mg/m 2 for 3 three-week cycles [n = 6 4 (7%)] Docetxel 75 mg/m 2, doxorubicin 50 mg/m 2, nd cyclophosphmide 500 mg/m 2 for 6 three-week cycles [n = 4 (7%)] Ptients underwent clinicl ssessments t bseline (pre-tretment), t the end of ech therpy cycle, nd t completion of the chemotherpy regimen. Assessments included photogrphs with 10-megpixel digitl cmer (PowerShot A3000 IS: Cnon, Melville, NY, U.S.A.) of the ptient s hed from 5 different views (frontl, right nd left lterl, occipitl, nd crown). In ddition, ech ptient completed self-dministered questionnire t bseline nd t the end of the entire chemotherpy regimen. The oncology nurses were trined to complete the cse report form using the World Helth Orgniztion (who) grding of cute nd subcute toxicity for lopeci 6, to tke photogrphs in stndrdized mnner (consistent lighting, positioning, nd distnce), nd to dminister the sclp-cooling tretment. Used in ccordnce with the mnufcturer s instructions, the DigniCp sclp cooling system pplies consistent temperture to the ptient s sclp before, during, nd fter ech chemotherpy cycle. An individully sized silicone cp, pplied together with neoprene cp, ensures proper fit for insultion. The ptient s hir is moistened before the cp is plced on her hed. A coolnt is then circulted through the system nd sensors regulte the temperture. The temperture setting ws determined ccording to the thickness of the ptient s hir (defult setting ws 5 C, with 3 C used for thicker hir). Before the strt of ech chemotherpy cycle, the study ptients underwent pre-drug cooling phse of 30 minutes. The overll length of the cooling time vried ccording to the chemotherpy regimen nd included post-drug cooling phse lsting between 60 nd 120 minutes. Specificlly, the post-drug cooling phse ws 120 minutes for epirubicin cyclophosphmide, for fluorourcil epirubicin cyclophosphmide, nd for docetxel doxorubicin cyclophosphmide; 100 minutes for docetxel nd for pclitxel crbopltin; 90 minutes for doxorubicin cyclophosphmide nd for docetxel cyclophosphmide; nd 60 minutes for weekly pclitxel. In ddition to stndrd ptient monitoring during chemotherpy, the oncology nurse recorded technicl complictions nd side effects experienced by the ptients during the course of the cooling process. To objectively determine the effectiveness of sclp cooling for preventing lopeci, the who recommendtions for grding cute nd subcute toxicity were used to ssess the degree of hir loss: Grde 0: no hir loss Grde 1: miniml hir loss (>0% to 25%) Grde 2: moderte, ptchy lopeci (>25% 75%) Grde 3: complete lopeci, but reversible (>75%) Grde 4: non-reversible lopeci (>75%) Subjective ssessment of the tolerbility nd efficcy of tretment used ptient stisfction mesure (scle of 0 100, nd question bout whether the ptient would recommend tretment to others) nd hed covering behvior (use of wig or scrf to cover the hed when outside the home). The dt collected were entered into n electronic dtbse for subsequent nlysis in the IBM SPSS Sttistics for Windows softwre ppliction (version 21.0: Armonk, NY, U.S.A.). In ddition to generting descriptive sttistics (centrl tendency nd vrince), inferentil sttistics using multivrite nlyses were obtined to compre results ccording to chemotherpy regimen (logistic regression using bckwrd likelihood rtio). Vribles entered into the multivrite model were chemotherpy regimen, ge, nd durtion (in minutes) of sclp cooling per chemotherpy cycle. A p vlue less thn 0.05 ws considered to indicte sttisticl significnce. RESULTS Ptient Chrcteristics nd Tretment The study enrolled 55 women [ethnicity: 52 white (95%), 3 Asin (5%)] who underwent chemotherpy between 2013 e577

3 nd Men ge t the time tht chemotherpy commenced ws 56 ± 12 yers (rnge: yers). Most of the study prticipnts (76%) were being treted for brest cncer (35 djuvnt, 5 pllitive, 2 neodjuvnt); 12 ptients (22%) were being treted for ovrin cncer, nd 1 ptient (1.8%), for endometril cncer. The medin durtion of the sclp-cooling tretment ws 3.5 hours, depending on the durtion of chemotherpy nd the post-drug cooling phse (interqurtile rnge: hours; rnge: hours). Of the 55 women, 43 (78%) completed the sclp-cooling tretment for the entirety of their chemotherpy regimen. Resons for cesstion of tretment in the remining 12 ptients were hir loss (n = 7), deth (n = 3), chnge of tretment centre (n = 1), nd doubts bout study prticiption which resulted in withdrwl of consent within 30 minutes of initition of the 1st cycle (n = 1). Of the women who terminted sclp-cooling tretment erly, only ptients who stopped becuse of hir loss (Tble i) were included in the remining nlyses (n = 50). Outcomes Objective Assessments According to the who lopeci grding system, the overll level of effectiveness of sclp-cooling tretment for preventing hir loss (grdes 0 1) ws 56% (28 of 50 ptients), which includes the women who stopped tretment erly. Tble ii presents the objectively mesured degree of hir loss nd tretment effectiveness ccording to chemotherpy regimen received. Subjective Assessments The medin score for ptient stisfction with the effectiveness of tretment ws 90% (interqurtile rnge: 60% 100%; rnge: 10% 100%). A stisfction score of 80% or better ws reported by 64% of the women. Recommendtion of the sclp-cooling tretment to other ptients ws endorsed by 36 women (72%); 10 (20%) sid tht they did not know; nd 4 (8%) would not recommend sclp cooling. A hed covering ws worn t some point during the tretment period by 26 women (52%). Tble iii presents the key subjective results ccording to chemotherpy regimen received. A combined successful outcome ws defined using both the objective mesure lopeci who grde 0 or 1 nd the subjective mesure no hed covering. Tble iv presents the combined objective nd subjective indictors ccording to chemotherpy regimen nd ptient ge. Using tht strict definition for success, the sttisticlly significnt predictors of miniml hir loss in the multivrite model were younger ge (p = 0.019) nd the pclitxel weekly (p = 0.012) nd pclitxel crbopltin (p = 0.023) regimens. Figure 1 illustrtes miniml hir loss in 32-yer-old brest cncer ptient who underwent neodjuvnt chemotherpy. Comprison of the objective nd subjective lopeci ssessment methods showed tht no womn with grde 0 ssessment used hed covering. However, of the 18 ptients with who grde 1 ssessment t the end of chemotherpy, 8 (44%) used hed covering when outside of their home, even though their result ws objectively defined s tretment success. With lopeci grde 2, the rte of hed covering ws 67% (8 of 12). All women with grde 3 hir loss used hed covering. No technicl difficulties or ptient-reported complictions were observed. Most ptients reported being resonbly comfortble throughout tretment, with the cold senstion t tolerble level. As previously mentioned, only 1 of the 55 prticipting ptients (1.8%) could not tolerte sclp cooling nd stopped tretment within the first 30 minutes. DISCUSSION Sclp hypothermi to prevent lopeci ims to reduce circultion to the sclp, leding to decresed perfusion of the hir follicles nd, ultimtely, to diminished intrfolliculr drug uptke nd metbolism 7. The vrious methods for sclp cooling include use of frozen cryogel in the shpe of helmet nd the circultion of cold ir or cold liquid in cp or helmet Drwbcks of those reported cooling methods include lck of consistent sclp temperture TABLE I Chrcteristics of the seven ptients who terminted sclp cooling during chemotherpy becuse of hir loss Cncer type Therpy type Age (yers) Chemotherpy regimen Averge cooling time per tretment (hours) Cycles completed t cesstion Grde of lopeci t cesstion Brest Neodjuvnt 40 TAC Brest Adjuvnt 50 TAC Brest Adjuvnt 45 FEC 3 D Brest Adjuvnt 46 AC 4 D Brest Adjuvnt 47 AC 4 D Brest Adjuvnt 76 Weekly pclitxel Ovrin 60 Pclitxel crbopltin World Helth Orgniztion grding: 0 = none; 1 = miniml hir loss (0% to 25%); 2 = moderte, ptchy lopeci (>25% to 75%); 3 = complete lopeci, but reversible (>75%); 4 = non-reversible lopeci (>75%). TAC = docetxel 75 mg/m 2, doxorubicin 50 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; FEC = fluorourcil 500 mg/m 2, epirubicin 100 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; D = docetxel 100 mg/m 2 every 3 weeks; AC = doxorubicin 60 mg/m 2, cyclophosphmide 600 mg/ m 2 every 3 weeks; weekly pclitxel = 80 mg/m 2 weekly; pclitxel crbopltin = pclitxel 175 mg/m 2 plus crbopltin 6 AUC (re under the curve) every 3 weeks. e578

4 TABLE II Objective ssessment of the effectiveness of sclp cooling t the end of chemotherpy or t cesstion of cooling tretment Chemotherpy regimen Ptients (n) by grde of lopeci Effectiveness (grdes 0 nd 1) Totl FEC 3 D % or AC 4 D 4 or EC 4 P 12 Pclitxel crbopltin % Weekly pclitxel % TC % TAC % TOTAL % World Helth Orgniztion grding: 0 = none; 1 = miniml hir loss (0% to 25%); 2 = moderte, ptchy lopeci (>25% to 75%); 3 = complete lopeci, but reversible (>75%); 4 = non-reversible lopeci (>75%). FEC = fluorourcil 500 mg/m 2, epirubicin 100 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; D = docetxel 100 mg/m 2 every 3 weeks; AC = doxorubicin 60 mg/m 2, cyclophosphmide 600 mg/m 2 every 3 weeks; EC = epirubicin 90 mg/m 2, cyclophosphmide 600 mg/m 2 every 3 weeks; P = pclitxel 80 mg/m 2 weekly; pclitxel crbopltin = pclitxel 175 mg/m 2 plus crbopltin 6 AUC (re under the curve) every 3 weeks; weekly pclitxel = 80 mg/m 2 weekly; TC = docetxel 75 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; TAC = docetxel 75 mg/m 2, doxorubicin 50 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks. TABLE III Subjective indictors of lopeci nd ptient stisfction by chemotherpy regimen Chemotherpy regimen Pts (n) 80 Stisfction with cooling tretment Indictor [n (%)] Recommend to others No hed scrf or wig used FEC 3 D (63) 16 (67) 9 (38) or AC 4 D 4 or EC 4 P 12 Pclitxel crbopltin (73) 10 (91) 7 (64) Weekly pclitxel (80) 3 (60) 4 (80) TC (67) 5 (83) 4 (67) TAC (25) 2 (50) 0 (0) TOTAL (64) 36 (72) 24 (48) FEC = fluorourcil 500 mg/m 2, epirubicin 100 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; D = docetxel 100 mg/m 2 every 3 weeks; AC = doxorubicin 60 mg/m 2, cyclophosphmide 600 mg/m 2 every 3 weeks; EC = epirubicin 90 mg/m 2, cyclophosphmide 600 mg/m 2 every 3 weeks; P = pclitxel 80 mg/m 2 weekly; pclitxel crbopltin = pclitxel 175 mg/m 2 plus crbopltin 6 AUC (re under the curve) every 3 weeks; weekly pclitxel = 80 mg/m 2 weekly; TC = docetxel 75 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; TAC = docetxel 75 mg/m 2, doxorubicin 50 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks. TABLE IV Effectiveness bsed on combined subjective nd objective indictors, by chemotherpy regimen nd ge Chemotherpy regimen No hed covering nd grde 0 or 1 lopeci [n/n (%)] Overll 50 Yers >50 Yers FEC 3 D 3 7/24 (30) 6/14 (43) 1/10 (10) or AC 4 D 4 or EC 4 P 12 Pclitxel crbopltin 6 7/11 (64) 4/4 (100) 3/7 (43) Weekly pclitxel 16 3/5 (60) 0/0 (0) 3/5 (60) TC 4 3/6 (50) 1/1 (100) 2/5 (40) TAC 6 0/4 (0) 0/3 (0) 0/1 (0) TOTAL 20/50 (40) 11/22 (50) 9/28 (32) World Helth Orgniztion grding: 0 = none; 1 = miniml hir loss (0% to 25%). FEC = fluorourcil 500 mg/m 2, epirubicin 100 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; D = docetxel 100 mg/m 2 every 3 weeks; AC = doxorubicin 60 mg/m 2, cyclophosphmide 600 mg/m 2 every 3 weeks; EC = epirubicin 90 mg/m 2, cyclophosphmide 600 mg/m 2 every 3 weeks; P = pclitxel 80 mg/m 2 weekly; pclitxel crbopltin = pclitxel 175 mg/m 2 plus crbopltin 6 AUC (re under the curve) every 3 weeks; weekly pclitxel = 80 mg/m 2 weekly; TC = docetxel 75 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; TAC = docetxel 75 mg/m 2, doxorubicin 50 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks. e579

5 FIGURE 1 (A,B) Before nd (C,D) fter imges of 32-yer-old brest cncer ptient who underwent sensor-controlled sclp cooling (Digni- Cp: Sysmex Europe GmbH, Norderstedt, Germny) while receiving neodjuvnt chemotherpy consisting of 4 cycles of doxorubicin 60 mg/ m 2 nd cyclophosphmide 600 mg/m 2 every 3 weeks, followed by 4 cycles of docetxel 100 mg/m 2 every 3 weeks. control, loosely fitted cps, weight of the cp, nd high worklod for the nursing stff to chnge the frozen cryogel cp every 30 minutes. The modern sclp cooling system used in the present study includes tight-fitting, light, soft silicone cps not covering the ers nd forehed. Lowering of the temperture is stepwise nd slow, nd the temperture of the sclp is mesured by 3 different sensors to mintin constnt hypothermi of the skin surfce 13. This sensor-controlled sclp cooling system showed high efficcy in preventing chemotherpy-induced lopeci in certin modern chemotherpy regimens (ssessed using subjective nd objective mesurements). With combined subjective nd objective success rte exceeding 50%, we believe tht sclp cooling cn be recommended for regimens such s pclitxel weekly nd the combintion regimens of docetxel cyclophosphmide nd pclitxel crbopltin. The combined success rte ws significntly higher in the pclitxel weekly nd pclitxel crbopltin regimens thn in the other regimens exmined. Conversely, with the triplet regimen docetxel doxorubicin cyclophosphmide, hir loss could not be prevented nd should not be recommended. For the sequentil polychemotherpy regimens fluorourcil epirubicin cyclophosphmide followed by docetxel or doxorubicin cyclophosphmide followed by docetxel, the success rte of the sclp cooling system ws 30%; cooling cn therefore be considered for younger ptients becuse ge ws multivrite prognostic fctor for lower level of hir loss. Our dt compre fvourbly with the lopeci rtes published for the sme regimens without sclp cooling (Tble v). For weekly pclitxel, complete lopeci ws reported to be 93.2% 14, nd for 6 cycles of docetxel monotherpy, the lopeci rte ws reported to be 100% 15. Accordingly, 6 cycles of polychemotherpy using docetxel doxorubicin cyclophosphmide or fluorourcil doxorubicin cyclophosphmide hd n lopeci rte higher thn 97.8% 16. For the sequentil regimen of fluorourcil epirubicin cyclophosphmide followed by docetxel, lopeci grde 3 or 4 hs been reported to be 92.6% 17. Our dt confirm findings reported by other reserchers using the sme sclp-cooling device. Schffrin-Nbe et l. 18 found lopeci grdes 0 1 in 68.4% of 76 brest cncer ptients fter 4 cycles of epirubicin cyclophosphmide followed by 12 weeks of weekly pclitxel. Our rte of objective grdes 0 1 with similr regimens ws 46%, with 38% of the ptients reporting no use of wig or scrf to cover the hed. Schffrin-Nbe et l. lso found tht premenopusl sttus ws ssocited with higher success rte of sclp cooling. Similrly, we found tht younger ge ws multivrite predictive fctor for less hir loss. Using nother sclp-cooling device (Pxmn PSC1 nd PSC2: Pxmn Coolers, Huddersfield, U.K.), vn den Hurk et l. 19 reported similr results: only 8% of their ptients receiving docetxel doxorubicin cyclophosphmide chemotherpy, 48% receiving fluorourcil epirubicin cyclophosphmide followed by docetxel, nd 81% receiving weekly pclitxel used no hed covering t the lst cycle of chemotherpy. However, they found tht only 38% of their 52 ptients receiving pclitxel crbopltin used no hed covering t the lst cycle, wheres 64% of our ptients did not use hed covering nd hd lopeci grde 0 or 1 fter 6 cycles of the sme chemotherpy. In our study, the low drop-out rte of 1.8% becuse of intolernce (1 of 55 ptients) reflects the high cceptbility of this sensor-controlled cooling cp nd is similr to the rte reported by Ridderheim et l. 13. Using nother sclp cooling device (Pxmn), intolernce to cooling ws reported to be 3% 19. A recent rndomized study showed tht the sclp cooling durtion could be shortened without reduction in efficcy, which might mke sclp cooling even more cceptble to ptients 20. Becuse the silicone cps of the DigniCp sclp cooling system re reusble, most of the cost is incurred with the initil purchse of the system nd with mintennce. In our helth cre system, the time spent t the outptient clinic for dministrtion of chemotherpy is covered by helth insurnce. Given the incresed time spent in the clinic by ptients hving sclp cooling, the initil investment is eventully repid ccording to cse lod. A limittion of our study ws tht control rm without sclp cooling ws bsent. Given the success rtes for lopeci prevention by this sclp cooling system in the literture (which ws communicted to ptients), control rm without sclp cooling ws believed to be unethicl, nd rndomized study ws therefore not fesible. Compring objective nd subjective lopeci ssessment methods reveled unexpected results. Although 18 ptients were clssified s hving who lopeci grde 1 t the end of their chemotherpy, 8 (44%) used hed covering when leving home. Tht finding highlights the importnce of both objective nd subjective ssessments of hir loss rther thn relince on one indictor of tretment success. We therefore believe tht compound endpoint including both the subjective need to wer hed covering nd n objective lopeci grde is more vlid wy to mesure the outcome of sclp cooling system. e580

6 TABLE V Comprtive subjective nd objective hir retention rtes Cooling system Ptients by chemotherpy regimen [% (n/n)] Reference Endpoints exmined Weekly pclitxel 16 Pclitxel crbopltin or docetxel crbopltin 6 Pclitxel crbopltin 12 EC 4 D 4 or AC 4 D 4 EC or AC 4 P 12 FEC 3 D 3 TC 4 TAC 6 DigniCp Ridderheim et l., No use of wig 63 (19/30) Friedrichs et l., Alopeci grde 0 or 1 b 54.8 (17/31) 28.6 (2/7) Schffrin-Nbe et l., No visible lopeci 42.9 (3/7) 100 (2/2) 50 (3/6) 68.4 (52/76) 58.3 (7/12) 100 (1/1) 29% (2/7) t lst cycle Current study No hed covering nd 60 (3/5) 64 (7/11) 55 (6/11) 11 (1/9) 0 (0/4) 50 (3/6) 0% (0/4) lopeci grde 0 or 1 b fter lst cycle Alopeci grde 0 or 1 b 80 (4/5) 73 (8/11) 64 (7/11) 22 (2/9) 50 (2/4) 67 (4/6) 25% (1/4) fter lst cycle CAP610 hypothermi cp c Auvinen et l., Alopeci grde 0-1* (18/22) fter finl cycle Pxmn d Vn den Hurk et l., No hed covering 81 (34/42) 38 (20/52) 75 (9/12) 63 (10/16) 48 (14/29) 48 (22/46) 8% (5/66) No sclp cooling Alopeci grde < 3 b % (Sto et l., ) (Pignt et l., ) (Fisher et l., ) (Roché et l., ) (Chevllier et l., ) (Mrtin et l., ) Sysmex Europe GmbH, Norderstedt, Germny. b World Helth Orgniztion grding: 0 = none; 1 = miniml hir loss (0% to 25%); 2 = moderte, ptchy lopeci (>25% to 75%); 3 = complete lopeci, but reversible (>75%); 4 = non-reversible lopeci (>75%). c Southwest Technologies, North Knss City, MO, U.S.A. d Pxmn Coolers, Huddersfield, U.K. Weekly pclitxel = 80 mg/m 2 weekly; pclitxel crbopltin = pclitxel 175 mg/m 2 plus crbopltin 6 AUC (re under the curve) every 3 weeks; docetxel crbopltin = docetxel 100 mg/m 2 plus crbopltin 6 AUC every 3 weeks; EC = epirubicin 90 mg/m 2, cyclophosphmide 600 mg/m 2 every 3 weeks; D = docetxel 100 mg/m 2 every 3 weeks; AC = doxorubicin 60 mg/m 2, cyclophosphmide 600 mg/m 2 every 3 weeks; P = pclitxel 80 mg/m 2 weekly; FEC = fluorourcil 500 mg/m 2, epirubicin 100 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; TC = docetxel 75 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks; TAC = docetxel 75 mg/m 2, doxorubicin 50 mg/m 2, cyclophosphmide 500 mg/m 2 every 3 weeks. CONCLUSIONS Results from studies of the rry of sclp cooling systems designed to prevent chemotherpy-induced lopeci, common nd psychologiclly troubling side effect for cncer ptients, hve vried. Our reserch showed tht the effectiveness of DigniCp, sensor-controlled sclp cooling system, depends on the chemotherpy regimen nd the ptient s ge. Becuse subjective nd objective indictors of success often differ, we recommend the use of compound endpoint to gin more insightful nd prcticl informtion to use in counselling ptients. ACKNOWLEDGMENTS The uthors cknowledge the contributions of oncology nurses Ayse Cpr nd Petr Mir, who diligently collected dt for this study. CONFLICT OF INTEREST DISCLOSURES We hve red nd understood Current Oncology s policy on disclosing conflicts of interest, nd we declre tht we hve none. AUTHOR AFFILIATIONS *Deprtment of Obstetrics nd Gynecology, Cntonl Hospitl Fruenfeld, Switzerlnd; Deprtment of Obstetrics nd Gynecology, Clinic of Kempten-Oberllgäu, Germny. e581

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