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

Centre Oscar Lambret

Status: Terminated

Conditions: Breast Cancer; Metastatic Breast Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02863146

HALACAP-1406

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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