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

NCT ID: NCT02863146

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-09-30

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.

Conditions

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Breast Cancer Metastatic Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role collaborator

Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurence VANLEMMENS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Monique Blondel

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Locations

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Centre Oscar Lambret

Lille, , France

Site Status

Countries

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France

Other Identifiers

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HALACAP-1406

Identifier Type: -

Identifier Source: org_study_id