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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02863146
• Other study ID #: HALACAP-1406
• Status: Terminated
• Phase: N/A
• First received: February 15, 2016
• Last updated: October 3, 2017
• Start date: May 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Eisai Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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