Efficacy of the Use of Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02863146|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : August 11, 2016
Last Update Posted : October 5, 2017
|Condition or disease|
|Breast Cancer Metastatic Breast Cancer|
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|
|Actual Enrollment :||23 participants|
|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|
- 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
- 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
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
|Centre Oscar Lambret|
|Lille, France, 59020|
|Principal Investigator:||Laurence VANLEMMENS, MD||Centre Oscar Lambret|
|Study Director:||Monique Blondel||Centre Oscar Lambret|