Preventing hair loss in breast cancer patients undergoing chemotherapy
Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation
This study is testing two different scalp-cooling methods to see if they can help women with breast cancer keep their hair while undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Months and up |
| Sex | Female |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Caen and 2 other locations) |
| Trial ID | NCT06011525 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of scalp refrigeration techniques to prevent chemotherapy-induced alopecia (CIA) in women with localized breast cancer receiving anthracycline and taxane-based chemotherapy. It aims to compare two different scalp-cooling methods while assessing their impact on patients' quality of life, self-image, and satisfaction with care. Additionally, the study will evaluate the economic aspects of each technique to guide future clinical decisions regarding CIA prevention. The research is conducted in France, focusing on a robust methodology to strengthen the evidence base for supportive care in chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with localized, non-metastatic breast cancer who are scheduled to receive specific chemotherapy regimens.
Not a fit: Patients with pre-existing alopecia, scalp dermatosis, or contraindications to scalp cooling will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for breast cancer patients by reducing the incidence of chemotherapy-induced hair loss.
How similar studies have performed: Previous studies have shown varying degrees of success with scalp cooling techniques, but this study aims to provide more definitive evidence on their effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Caen and 2 other locations
- centre François Baclesse — Caen, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- IUCT-Oncopole — Toulouse, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Rose-Marie CHARLES
- Email: rm.charles@baclesse.unicancer.fr
- Phone: +33231458648
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.