Spots Global Cancer Trial Database for Prevention of Alopecia in Patients With Localised Breast Cancer

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Trial Identification

Brief Title: Prevention of Alopecia in Patients With Localised Breast Cancer

Official Title: Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation

Study ID: NCT06011525

Conditions

Chemotherapy-induced Alopecia

Interventions

standard cold cap

scalp-cooling technique

Study Description

Brief Summary: The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy. This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.

Detailed Description: