Efficacy of the Use of Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Breast Cancer

Study Overview
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Brief Summary
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HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.

Detailed Description
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A nurse will meet the patient and present the study, then the patient will be invited to participate. If the patient is interested, an information note will be given and the non-opposition of the patient will be collected. Patients will be registered via a registration form and an inclusion number will be attributed at each patient. Eribulin will be used within the framework of its marketing authorization, per cycle of 21 days, at day 1 and day 8. Modalities of refrigerant helmet use will be set according to the habits of the Oscar Lambret center with the following rules : Placement of a single-use non-woven hygiene cap on the scalp T-15 minutes: placement of the refrigerant helmet T0: begin of eribulin infusion (duration: 2-5 minutes) T+15 minutes: rinse of the line T+30 minutes: withdrawal of the helmet Efficacy will be evaluated before treatment and at each eribulin cycle.

Official Title
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Efficacy of the Use of a Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Locally Advanced or Metastatic Breast Cancer Pretreated With Anthracyclines and Taxanes

Conditions
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Breast Cancer, Metastatic Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient who has a locally advanced or metastatic breast cancer Indication of Halaven treatment : patient pretreated with anthracyclines or taxanes, patient who has received at least 1 chemotherapy regimen for their advanced or metastatic stage Patient who has had enough time to have retrieved her hair or whose last chemotherapy regimen didn't induce alopecia. Aged ≥ 18 years Non-opposition of the patient must have been collected Exclusion Criteria: Skin metastasis of the scalp Sensitivity to cold, cold agglutinin disease or cryoglobulinemia Impossibility to submit at the study procedures due to geographic, social or mental reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alopecia grade after 3 cycles of eribulin according to NCI-CTCAE v4.0 | Efficacy of the refrigerant helmet : Alopecia grade after 3 cycles of eribulin | on the day 1 of cycle 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events graded according to NCI-CTCAE v4.0 | Tolerance of the refrigerant helmet : graduation of adverse events lived by patients | every 28 days : at day 1 of each cycle during 3 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced breast cancer, alopecia, eribulin