Prevention of Alopecia in Patients With Localised Breast Cancer (ICELAND)

Centre Francois Baclesse

Status: Enrolling

Conditions: Chemotherapy-induced Alopecia

Treatments: Other: scalp-cooling technique; Other: standard cold cap

Study type: Interventional

Funder types: Other

Identifiers

NCT06011525

2023-A00769-36

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: Female

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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 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 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

standard cold-cap

Active Comparator group

Description:

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.

Treatment:

Other: standard cold cap

scalp-cooling technique

Experimental group

Description:

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.

Treatment:

Other: scalp-cooling technique