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Trial record 94 of 157 for:    eribulin

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

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ClinicalTrials.gov Identifier: NCT02863146
Recruitment Status : Terminated (Lack of enrollment)
First Posted : August 11, 2016
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease
Breast Cancer Metastatic Breast Cancer

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.


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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : May 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Eribulin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863146


Locations
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France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Eisai Inc.
Investigators
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Principal Investigator: Laurence VANLEMMENS, MD Centre Oscar Lambret
Study Director: Monique Blondel Centre Oscar Lambret

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02863146     History of Changes
Other Study ID Numbers: HALACAP-1406
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
locally advanced breast cancer
alopecia
eribulin

Additional relevant MeSH terms:
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Breast Neoplasms
Alopecia
Alopecia Areata
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical