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Prevention of Alopecia in Patients With Localised Breast Cancer
Sponsor: Centre Francois Baclesse
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.
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
Key Details
Gender
FEMALE
Age Range
18 Months - Any
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2023-08-03
Completion Date
2028-09-08
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
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.
scalp-cooling technique
Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment
Locations (3)
centre François Baclesse
Caen, France
Centre Oscar Lambret
Lille, France
IUCT-Oncopole
Toulouse, France