{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T17:42:25Z","timestamp":1786642945198,"version":"build-2736575974"},"reference-count":25,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"PAXMAN","award":["Supply of automated scalp cooling Paxman PCS2 (no grant number)"],"award-info":[{"award-number":["Supply of automated scalp cooling Paxman PCS2 (no grant number)"]}]},{"name":"French Health Ministry","award":["PHRIP n\u00b0 21-0015"],"award-info":[{"award-number":["PHRIP n\u00b0 21-0015"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"\n Background<\/jats:title>\n Chemotherapy-induced alopecia (CIA) remains one of the most distressing adverse effects for patients with localized breast cancer receiving anthracycline and taxane-based chemotherapy regimens. Although automated scalp cooling systems and standard non-automated cold-cap devices have demonstrated efficacy in reducing CIA, controlled trials with direct randomization comparing these two modalities of scalp cooling are lacking. This study aims to compare clinical efficacy, patient-reported outcomes, and medico-economic impact of a scalp cooling system (PAXMAN\u00ae PSCS 2) versus standard cold-cap therapy in preventing CIA.<\/jats:p>\n <\/jats:sec>\n \n Methods\/Design<\/jats:title>\n ICELAND is a prospective, multicenter, open-label, randomized controlled phase III trial conducted in three French cancer centers. This study addresses female adult patients with histologically confirmed, non-metastatic breast cancer, scheduled to receive neoadjuvant or adjuvant chemotherapy with epirubicin-cyclophosphamide (3 or 4 cycles) followed by either docetaxel (3 cycles) or paclitaxel (9\u201312 weekly cycles) as per routine practice. A total of 196 patients will be 1:1 randomized to automated scalp cooling device (experimental arm) or standard non-automated cold-cap therapy (control arm), with stratification on chemotherapy regimen, menopausal status and centre. The primary endpoint is the proportion of patients experiencing no more than half hair loss (NCI-CTCAE v5.0 grade 0\u20131) from baseline to chemotherapy completion, as assessed by blinded central review of standardized photographs. Secondary endpoints include: degree of CIA before taxane initiation; hair regrowth 6 months after the end of chemotherapy; patient adherence and comfort for each scalp cooling modality; body image (BIS); quality of life (EORTC QLQ-C30\/BR23); anxiety\/depression (HADS); satisfaction with care (OUTPATSAT-35-CT); return to work; nursing time associated with device use; and cost-utility in QALYs.<\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n This study will provide the first high-quality randomized evidence directly comparing scalp cooling and standard cold-cap use for CIA prevention in localized breast cancer. The results will inform both clinical practice and health policy by integrating clinical efficacy, patient-reported outcomes, and medico-economic considerations.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n \n ClinicalTrials.gov\n NCT06011525<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pone.0354676","type":"journal-article","created":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T17:25:36Z","timestamp":1786641936000},"page":"e0354676","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Scalp cooling versus standard cold-cap in preventing chemotherapy-induced alopecia in patients with localized breast cancer: ICELAND protocol, a randomized controlled trial and economic evaluation"],"prefix":"10.1371","volume":"21","author":[{"given":"Fran\u00e7ois","family":"Gernier","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justine","family":"Lequesne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Michel","family":"Grellard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Fernette","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laetitia","family":"Gigan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5543-8929","authenticated-orcid":true,"given":"Adeline","family":"Morel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrien","family":"Estienne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herv\u00e9","family":"Castel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Lahaye","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiphaine","family":"Leroux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rose-Marie","family":"Charles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Dupont","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Zarca","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Dereumaux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-C\u00e9cile","family":"Rouanet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4078-1476","authenticated-orcid":true,"given":"Isabelle","family":"Durand-Zaleski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0543-732X","authenticated-orcid":true,"given":"B\u00e9n\u00e9dicte","family":"Clarisse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,8,13]]},"reference":[{"issue":"3","key":"pone.0354676.ref001","doi-asserted-by":"crossref","first-page":"627","DOI":"10.1007\/s10549-018-4855-2","article-title":"Persistent major alopecia following adjuvant docetaxel for breast cancer: incidence, characteristics, and prevention with scalp cooling","volume":"171","author":"M Mart\u00edn","year":"2018","journal-title":"Breast Cancer Res Treat"},{"issue":"3","key":"pone.0354676.ref002","doi-asserted-by":"crossref","first-page":"414","DOI":"10.1634\/theoncologist.2018-0184","article-title":"Permanent Chemotherapy-Induced Alopecia in Patients with Breast Cancer: A 3-Year Prospective Cohort Study","volume":"24","author":"D Kang","year":"2019","journal-title":"Oncologist"},{"issue":"4","key":"pone.0354676.ref003","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1002\/pon.1245","article-title":"Chemotherapy-induced alopecia and effects on quality of life among women with breast cancer: a literature review","volume":"17","author":"J Lemieux","year":"2008","journal-title":"Psychooncology"},{"issue":"1","key":"pone.0354676.ref004","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/j.clbc.2017.07.012","article-title":"Scalp Hypothermia for Preventing Alopecia During Chemotherapy. A Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"18","author":"HS Rugo","year":"2018","journal-title":"Clin Breast Cancer"},{"issue":"6","key":"pone.0354676.ref005","doi-asserted-by":"crossref","DOI":"10.1097\/NCC.0000000000000899","article-title":"Interventions for Preventing Chemotherapy-Induced Alopecia: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials","volume":"44","author":"T Zhou","year":"2021","journal-title":"Cancer Nurs"},{"issue":"3","key":"pone.0354676.ref006","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1007\/s10549-009-0342-0","article-title":"Incidence of scalp metastases in breast cancer: a retrospective cohort study in women who were offered scalp cooling","volume":"118","author":"J Lemieux","year":"2009","journal-title":"Breast Cancer Res Treat"},{"issue":"2","key":"pone.0354676.ref007","doi-asserted-by":"crossref","first-page":"226","DOI":"10.1188\/17.CJON.226-233","article-title":"Scalp Cooling: A Literature Review of Efficacy, Safety, and Tolerability for Chemotherapy-Induced Alopecia","volume":"21","author":"M Ross","year":"2017","journal-title":"Clin J Oncol Nurs"},{"issue":"2","key":"pone.0354676.ref008","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1007\/s10549-017-4185-9","article-title":"Scalp cooling with adjuvant\/neoadjuvant chemotherapy for breast cancer and the risk of scalp metastases: systematic review and meta-analysis","volume":"163","author":"HS Rugo","year":"2017","journal-title":"Breast Cancer Res Treat"},{"key":"pone.0354676.ref009","first-page":"369","article-title":"Effectiveness, safety, and tolerance of scalp cooling for chemotherapy-induced alopecia","volume":"49","author":"XY Zhang","year":"2022","journal-title":"Oncol Nurs Forum"},{"issue":"1","key":"pone.0354676.ref010","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1007\/s10549-025-07858-5","article-title":"Adverse effects of scalp cooling for the reduction of chemotherapy-induced alopecia: A systematic review and meta-analysis","volume":"215","author":"CA Kearney","year":"2025","journal-title":"Breast Cancer Res Treat"},{"issue":"1","key":"pone.0354676.ref011","first-page":"305","article-title":"Barriers and enablers to implementing scalp cooling in Australia: a qualitative study of health professionals\u2019 attitudes to and experience with scalp cooling","volume":"26","author":"JM Shaw","year":"2018","journal-title":"Support Care Cancer"},{"issue":"2","key":"pone.0354676.ref012","doi-asserted-by":"crossref","DOI":"10.1200\/OP.21.00273","article-title":"Identifying Barriers and Facilitators to Scalp Cooling Therapy Through a National Survey of the Awareness, Practice Patterns, and Attitudes of Oncologists","volume":"18","author":"M Novice","year":"2022","journal-title":"JCO Oncol Pract"},{"issue":"9","key":"pone.0354676.ref013","first-page":"2565","article-title":"Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment","volume":"21","author":"DC Betticher","year":"2013","journal-title":"Support Care Cancer"},{"issue":"6","key":"pone.0354676.ref014","doi-asserted-by":"crossref","first-page":"766","DOI":"10.1016\/S0959-8049(00)00012-5","article-title":"Prevention of chemotherapy-induced alopecia using an effective scalp cooling system","volume":"36","author":"P Katsimbri","year":"2000","journal-title":"Eur J Cancer"},{"issue":"1","key":"pone.0354676.ref015","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1007\/s10549-017-4506-z","article-title":"Registry study to assess hair loss prevention with the Penguin Cold Cap in breast cancer patients receiving chemotherapy","volume":"167","author":"BA Rice","year":"2018","journal-title":"Breast Cancer Res Treat"},{"issue":"3","key":"pone.0354676.ref016","doi-asserted-by":"crossref","first-page":"277","DOI":"10.4103\/apjon.apjon_4_19","article-title":"Scalp Cooling in Daily Clinical Practice for Breast Cancer Patients Undergoing Curative Chemotherapy: A Multicenter Interventional Study","volume":"6","author":"E Gianotti","year":"2019","journal-title":"Asia Pac J Oncol Nurs"},{"key":"pone.0354676.ref017","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.breast.2018.04.012","article-title":"Scalp cooling successfully prevents alopecia in breast cancer patients undergoing anthracycline\/taxane-based chemotherapy","volume":"40","author":"I Vasconcelos","year":"2018","journal-title":"Breast"},{"issue":"2","key":"pone.0354676.ref018","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1016\/S0959-8049(00)00353-1","article-title":"A body image scale for use with cancer patients","volume":"37","author":"P Hopwood","year":"2001","journal-title":"Eur J Cancer"},{"issue":"5","key":"pone.0354676.ref019","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1093\/jnci\/85.5.365","article-title":"The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology","volume":"85","author":"NK Aaronson","year":"1993","journal-title":"J Natl Cancer Inst"},{"issue":"10","key":"pone.0354676.ref020","doi-asserted-by":"crossref","first-page":"2756","DOI":"10.1200\/JCO.1996.14.10.2756","article-title":"The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study","volume":"14","author":"MA Sprangers","year":"1996","journal-title":"J Clin Oncol"},{"issue":"6","key":"pone.0354676.ref021","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1111\/j.1600-0447.1983.tb09716.x","article-title":"The hospital anxiety and depression scale","volume":"67","author":"AS Zigmond","year":"1983","journal-title":"Acta Psychiatr Scand"},{"issue":"3","key":"pone.0354676.ref022","first-page":"315","article-title":"Multisite validation study of questionnaire assessing out-patient satisfaction with care questionnaire in ambulatory chemotherapy or radiotherapy treatment","volume":"93","author":"R Poinsot","year":"2006","journal-title":"Bull Cancer"},{"key":"pone.0354676.ref023","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1186\/s12955-020-01611-w","article-title":"Mapping EORTC QLQ-C30 and FACT-G onto EQ-5D-5L index for patients with cancer","volume":"18","author":"Y Hagiwara","year":"2020","journal-title":"Health Qual Life Outcomes"},{"key":"pone.0354676.ref024","doi-asserted-by":"crossref","first-page":"413","DOI":"10.1007\/s40273-019-00876-4","article-title":"A French value set for the EQ-5D-5L","volume":"38","author":"LF Andrade","year":"2020","journal-title":"Pharmacoeconomics"},{"issue":"3","key":"pone.0354676.ref025","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1111\/j.1756-5391.2009.01023.x","article-title":"Balancing treatment allocations by clinician or center in randomized trials allows unacceptable levels of treatment prediction","volume":"2","author":"RK Hills","year":"2009","journal-title":"J Evid Based Med"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0354676","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T17:25:40Z","timestamp":1786641940000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0354676"}},"subtitle":[],"editor":[{"given":"Li-Ping","family":"Liu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,8,13]]},"references-count":25,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8,13]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0354676","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,13]]}}}