Prevention of Alopecia in Patients With Localised Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Chemotherapy-induced Alopecia

Intervention / Treatment
-----------------
* Other: standard cold cap
* Other: scalp-cooling technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: History of neck pain Pre-existing alopecia Participation in another trial Dermatosis of the scalp Contraindication to scalp cooling History of migraines, stroke or hyperthyroidism History of scalp metastases Sensitivity to cold, cold agglutinin disease, cryoglobulinaemia, cryofibrinogenaemia or post-traumatic cold dystrophy. Malignant haemopathies History of chemotherapy treatment Indication for cerebral irradiation Pregnant or breast-feeding patient Raynaud's syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Months

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard cold-cap<br>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. | Other: standard cold cap<br>* 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.<br>|
| Experimental: scalp-cooling technique<br>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. | Other: scalp-cooling technique<br>* Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the grade of the patient alopecia. | The grade of patient alopecia will be be evaluated by NCI-CTCAE | At 6 months after treatment start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alopecia, chemotherapy-induced