Weight Variation During Chemotherapy in Breast Cancer Pat... | NCT01506466

Studies
Weight Variation During Chemotherapy in Breast Cancer Patients

NCT01506466

Sponsor

Centre Jean Perrin

Status

Completed

Last Update Posted

Jul 24, 2015Estimated

Enrollment

52Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

blood test/ additional measurement

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jan 3, 2012

First Submission Date that Met QC Criteria

Jan 5, 2012

First Posted Date

Jan 10, 2012Estimated

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

Jul 23, 2015

Last Update Posted Date

Jul 24, 2015Estimated

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

Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.

Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
additional examinations/measurements	Other		Other: blood test/ additional measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood test/ additional measurement	Other	blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation	additional examinations/measurements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in body composition		within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in energy balance	resting energy expenditure, physical activity, food records.	within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Change from baseline in muscle strength

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

menopausal women
breast cancer
patients requiring chemotherapy treatment
WHO performance status 0-2

Exclusion Criteria:

diabetics
patients with metastases
other cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xavier DURANDO, MD, PhD	Centre Jean Perrin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Jean Perrin		Clermont-Ferrand		63000	France

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D001835	Body Weight

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided