Efficacy of the Use of Refrigerant Helmet to Prevent Alop... | NCT02863146

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

NCT02863146

Sponsor

Centre Oscar Lambret

Status

Terminated

Last Update Posted

Oct 5, 2017Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Breast Cancer
Metastatic Breast Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Feb 15, 2016

First Submission Date that Met QC Criteria

Aug 8, 2016

First Posted Date

Aug 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2017

Last Update Posted Date

Oct 5, 2017Actual

Name	Class
Eisai Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurence VANLEMMENS, MD	Centre Oscar Lambret	Principal Investigator
Monique Blondel	Centre Oscar Lambret	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Oscar Lambret		Lille		59020	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D000505	Alopecia

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

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