Prevention of Alopecia in Patients With Localised Breast Cancer (NCT06011525) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prevention of Alopecia in Patients With Localised Breast Cancer
France196 participantsStarted 2023-08-03
Plain-language 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.
Who can participate
Age range
18 Months
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.