NCT06011525Active, not recruiting
Prevention of Alopecia in Patients With Localised Breast Cancer
Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 3 Aug 2023
- Start date
- 3 Aug 2023
- Primary completion date
- 3 Sept 2026
- Lead sponsor
- Centre Francois Baclesse
- Diseases
- Childhood cancers
- NCT number
- NCT06011525
What you commit to
- Study type: Interventional
- Planned participants: 196
- From 3 Aug 2023 to the primary completion date, 3 Sept 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for cerebral irradiation
Other illness
- History of neck pain
- 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
- Raynaud's syndrome
Other
- Pre-existing alopecia
- Participation in another trial
- Dermatosis of the scalp
- Contraindication to scalp cooling
- Pregnant or breast-feeding patient
Who the study is looking for
- 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
Age in the registry: 18 months to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| IUCT Oncopôle Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.