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
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 1
Healthy Volunteers: f
View:

• Age \>18

• Female

• Histologically proven diagnosis of localised, non-metastatic breast cancer

• Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 EC100 followed by 3 Docetaxel or 3 EC100 plus 12 Paclitaxel); HER-positive status is not a non-inclusion criterion.

• Patient willing to be photographed to assess IFA

• Fluency in French

• Patient affiliated to a social security scheme

• Signature of informed consent

Locations
Other Locations
France
centre François Baclesse
RECRUITING
Caen
Centre Oscar Lambret
NOT_YET_RECRUITING
Lille
IUCT-Oncopole
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Rose-Marie CHARLES
rm.charles@baclesse.unicancer.fr
+33231458648
Backup
François GERNIER
f.gernier@baclesse.unicancer.fr
Time Frame
Start Date: 2023-08-03
Estimated Completion Date: 2026-09-03
Participants
Target number of participants: 196
Treatments
Active_comparator: standard cold-cap
Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.~This device will be supplemented by a compression bandage to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the effectiveness of the device.
Experimental: scalp-cooling technique
Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
Sponsors
Leads: Centre Francois Baclesse

This content was sourced from clinicaltrials.gov