RecruitingNot ApplicableNCT06011525

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

Sponsor

Centre Francois Baclesse

Enrollment

196 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Chemotherapy-induced Alopecia

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.

Eligibility

Sex: FEMALEMin Age: 18 Months

Plain Language Summary

Simplified for easier understanding

This study is testing whether scalp cooling (a technique that reduces blood flow to the scalp during chemotherapy) can prevent hair loss in women with localised breast cancer undergoing anthracycline and taxane chemotherapy in France. **You may be eligible if...** - You are a woman over 18 - You have been diagnosed with localised (non-metastatic) breast cancer confirmed by biopsy - You are scheduled to receive neo-adjuvant or adjuvant anthracycline and taxane chemotherapy - You are fluent in French and have signed consent - You are affiliated with a social security scheme in France **You may NOT be eligible if...** - You have a history of neck pain, migraines, stroke, or hyperthyroidism - You already have hair loss (alopecia) - You have a scalp skin condition or a contraindication to scalp cooling - You have Raynaud's syndrome or sensitivity to cold - You are pregnant or breastfeeding - You have had prior chemotherapy - Brain radiation is planned - You have blood cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERstandard 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.

OTHERscalp-cooling technique

Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment

Locations(3)

centre François Baclesse

Caen, France

Centre Oscar Lambret

Lille, France

IUCT-Oncopole

Toulouse, France

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NCT06011525

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