RecruitingNot ApplicableNCT06011525

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

Sponsor

Centre Francois Baclesse

Enrollment

196 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Chemotherapy-induced Alopecia

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

Sex: FEMALEMin Age: 18 Months

Inclusion Criteria8

Age \>18
Female
Histologically proven diagnosis of localised, non-metastatic breast cancer
Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 or 4 EC100 followed by 3 Docetaxel or 3 or 4 EC100 plus 9 to 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 Criteria13

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

Interventions

OTHERstandard 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.

OTHERscalp-cooling technique

Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment