Original Title: Efficacité et innocuité des casques réfrigérants pour prévenir l’alopécie induite par la chimiothérapie

Authors' objectives: Chemotherapy-induced alopecia (CIA) is a side effect that can occur two to four weeks after the start of treatment. It can affect up to 65% of patients, depending on the type and dose of chemotherapy used. Although harmless and often reversible within three to six months, hair loss affects body image and can have a marked negative impact on the physical and psychological well-being of some patients. Scalp cooling (SC) with a cooling cap has been used since the 1970s to reduce the incidence of CIA in patients treated for solid cancers. The technique is based on the vasoconstriction principle and reduced blood flow associated with cold, thus reducing the effect of chemotherapy on hair follicles. Two technologies are available: manual device, a cap containing pre-cooled gel, and automatic system, an automated device that circulates a continuously cooled fluid through a helmet. This technology is offered on a limited basis in certain Quebec centers, and clinicians are often questioned by their patients about its effectiveness and safety. At the same time, issues are being raised about access equity and how best to deliver this technology in a resource-constrained situation. The Direction cancérologie du Ministère de la Santé et des Services sociaux (MSSS) has asked the INESSS to produce a state-of--knowledge report on the effectiveness and safety of SC for the prevention of CIA. This document will support the MSSS in its reflexions on the accessibility and dispensing of this service.

Authors' results and conclusions: RESULTS (#1 CHEMOTHERAPY-INDUCED ALOPECIA (CIA)): Although its incidence varies between 24% and 48% according to registries, it can reach up to 65% of treated patients, depending on the type and dose of chemotherapy used. • Anthracyclines (doxorubicin and epirubicin), taxanes (notably docetaxel and paclitaxel) and alkylating agents (cyclophosphamide and ifosfamide) can cause alopecia to varying degrees of severity. (#2 METHODOLOGICAL LIMITATIONS): The quality of the included studies was judged to be low to moderate. These included significant methodological limitations that may affect the reliability, validity and transferability of results. – The treatments included in these studies are varied and include taxanes (docetaxel: 50 – 100 mg/m2; paclitaxel: 80 mg/m2), anthracyclines (epirubicin: 75 – 100 mg/m2; adriamycin: 50 – 60 mg/m2), cyclophosphamide: (500 – 600 mg/m2) and fluorouracil: (500 – 600 mg/m2). – The variety of doses and the various combinations of molecules between studies make it difficult to compare results. – SC results obtained in the course of a given chemotherapy treatment are not transferable to other types of treatment. • SC effectiveness is measured using validated scales for adverse effects in general, but not specifically for hair loss. In addition, various measurement scales are used, sometimes modified, reducing their internal validity, making the results less reliable and homogeneous. (#3 EFFECTIVENESS OF SCALP COOLING): • Very little evidence is available to assess relative SC effectiveness in relation to chemotherapy regimen or dose. – Several authors believe that SC effectiveness depends on the regimens and doses used. – SC effectiveness appears to be lower with the use of anthracyclines. (#4 PATIENT SATISFACTION AND QUALITY OF LIFE): Using a SC does not seem to affect patients' quality of life. It would be comparable to that observed in the absence of SC use for the dimensions measured in the studies, such as overall health, emotional status, social functioning, anxiety, depression and body image. (#5 SIDE EFFECTS AND SAFETY ): Reported side effects are minor to moderate, rarely severe, in the majority of cases. The most frequent are headaches, cold sensations, chills, scalp sensitivity and pain. They may be the cause of SC session discontinuation (in 6% to 34% of patients using automatic SC, and up to 41% of patients using manual cap). (#6 VARIED POSITIONS OF CERTAIN COUNTRIES, ORGANIZATIONS AND AGENCIES ON THE USE OF CHS): Most organizations recognize the weakness of scientific evidence for SC use. • Some organizations recommend SC use on condition that it is indicated by the healthcare team, for a specific indication and for particular chemotherapy protocols; however, without specifying the details. (#7 SC USE IN QUEBEC): In Quebec, very few centers appear to offer SC supervision. Two centers offering SC were identified (one with manual SC cap, the other with automatic system). Experience and practice vary from place to place (type of device, clinician involvement). (#8 ORGANIZATIONAL IMPACT OF SC USE): • The use of scalp cooling requires a high level of involvement on the part of nursing staff: – the collaboration of clinicians or a person assigned to this task, depending on the technology used (cleaning, and storage of manual helmets and supervision of automatic SC operation); – staff training in the use of the type of SC involved; – review of certain chemotherapy dispensing processes. • Caring for and supervising patients during cooling sessions adds an additional workload for nursing staff, particularly in terms of care planning to avoid affecting the chemotherapy sessions of other patients. CONCLUSION: Based on the available evidence, SC use appears to reduce the risk of CIA and improve hair regrowth in breast cancer patients who have received chemotherapy. This finding is based on data from clinical trials of low to moderate quality, with numerous methodological limitations. Additional data from clinical trials of higher methodological quality will be required to confirm this finding. No significant differences were demonstrated based on the type of SC device used (manual or automatic). Reported side effects are minor to moderate, rarely severe, in the majority of cases. The incidence of scalp metastases does not appear to be higher following SC use. Quality of life does not appear to be improved by the use of SC intervention. Significant organizational issues that may affect the delivery of services to other patients need to be considered regarding SC use in cancer centers, including the involvement required of nursing staff in the preparation and supervision of sessions, increased chair time, and the purchase and maintenance of technology.

Authors' methods: A review of the scientific and grey literature was conducted, targeting randomized or nonrandomized clinical trials and systematic reviews with or without meta-analysis. Studies published in the last ten years (2014 to 2023), in French and English, were selected, supplemented by updates up to the final submission of the document. The grey literature search targeted documents published by official organizations in selected countries and Canadian provinces. A methodological quality assessment was conducted on the selected studies. Some consultations with key informants were conducted to obtain information on the supply and demand for SC in Quebec. In addition, a validation process for the selected information was conducted by members of the Comité de l'évolution des pratiques en oncologie (CEPO). The committee members were consulted during the project, and commented on the relevance of the assessment questions, the analysis of available data, and the clinical and organizational issues associated with this technology.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/les-casques-refrigerants-efficacite-et-innocuite-pour-prevenir-lalopecie-induite-par-la-chimiotherapie.html

Year Published: 2025

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/les-casques-refrigerants-efficacite-et-innocuite-pour-prevenir-lalopecie-induite-par-la-chimiotherapie.html

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)