Prevention of Alopecia in Patients With Localised Breast Cancer

Chemotherapy-induced Alopecia Clinical Trial

— ICELAND  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011525
• Other study ID #: 2023-A00769-36
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: September 3, 2026

Study information

• Verified date: August 2023
• Source: Centre Francois Baclesse
• Contact: Rose-Marie CHARLES
• Phone: +33231458648
• Email: rm.charles[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: September 3, 2026
• Est. primary completion date: September 3, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Chemotherapy-induced Alopecia

Intervention

Other:
• standard 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.
• scalp-cooling technique
Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment

Locations

Country	Name	City	State
France	centre François Baclesse	Caen
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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