Status:
RECRUITING
Prevention of Alopecia in Patients With Localised Breast Cancer
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Chemotherapy-induced Alopecia
Eligibility:
FEMALE
18+ years
Phase:
NA
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 methodologie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 3 2026
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06011525
Start Date
August 3 2023
End Date
September 3 2026
Last Update
July 11 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
centre François Baclesse
Caen, France, 14000
2
Centre Oscar Lambret
Lille, France
3
IUCT-Oncopole
Toulouse, France