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

October 3, 2017 updated by: Centre Oscar Lambret

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alopecia grade after 3 cycles of eribulin according to NCI-CTCAE v4.0
Time Frame: on the day 1 of cycle 4
Efficacy of the refrigerant helmet : Alopecia grade after 3 cycles of eribulin
on the day 1 of cycle 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events graded according to NCI-CTCAE v4.0
Time Frame: every 28 days : at day 1 of each cycle during 3 cycles
Tolerance of the refrigerant helmet : graduation of adverse events lived by patients
every 28 days : at day 1 of each cycle during 3 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

Eisai Inc.

Investigators

  • Principal Investigator: Laurence VANLEMMENS, MD, Centre Oscar Lambret
  • Study Director: Monique Blondel, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HALACAP-1406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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