NCT02863146

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Breast Cancer
• Metastatic Breast Cancer

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2016-08-11
• Last updated: 2017-10-05

Locations

1 site across 1 country: France