- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lille, France, 59020
- Centre OSCAR LAMBRET
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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Efficacy of the refrigerant helmet : Alopecia grade after 3 cycles of eribulin
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on the day 1 of cycle 4
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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
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Tolerance of the refrigerant helmet : graduation of adverse events lived by patients
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every 28 days : at day 1 of each cycle during 3 cycles
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurence VANLEMMENS, MD, Centre OSCAR LAMBRET
- Study Director: Monique Blondel, Centre OSCAR LAMBRET
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HALACAP-1406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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