Prevention of Alopecia in Patients With Localised Breast Cancer

Not Applicable

Recruiting

• Conditions: Chemotherapy-induced Alopecia
• Interventions: Other: standard cold cap; Other: scalp-cooling technique

• Registration Number: NCT06011525
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-03
• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-09-03
• Study Completion: 2026-09-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard cold-cap	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.
scalp-cooling technique	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.

Primary Outcome Measures

Name	Time	Method
Compare the grade of the patient alopecia.	At 6 months after treatment start	The grade of patient alopecia will be be evaluated by NCI-CTCAE

Trial Locations

Locations (2)

centre François Baclesse; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France