NCT06011525

Prevention of Alopecia in Patients With Localised Breast Cancer

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Centre Francois Baclesse · Academic / Other
• Sex: Female
• Age: 18 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-induced Alopecia

Interventions

Type	Name	Description
OTHER	standard cold cap	Standard cold-cap applied throughout anthracycline- and taxane-based chemotherapy treatment. This device will be supplemented by a compressive bandage in order to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the efficacy of the device.
OTHER	scalp-cooling technique	Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment

Timeline

• Start date: 2023-08-03
• Primary completion: 2026-09-03
• Completion: 2028-09-08
• First posted: 2023-08-25
• Last updated: 2026-01-13

Locations

3 sites across 1 country: France