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

NCT02863146 | Terminated

• 1 other identifier: HALACAP-1406
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Metastatic Breast Cancer

Keywords

locally advanced breast cancer; alopecia; eribulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events graded according to NCI-CTCAE v4.0

  every 28 days : at day 1 of each cycle during 3 cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Locally advanced or metastatic breast cancer patients treated with eribulin and whose cancer has progressed after at least 1 chemotherapy regimen for their advanced stage

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Eisai Inc.: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Alopecia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurence VANLEMMENS, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

• Monique Blondel

  Centre Oscar Lambret

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: August 11, 2016
• Study Start: May 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)