Weight Variation During Chemotherapy in Breast Cancer Patients

NCT ID: NCT01506466

Last Updated: 2015-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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additional examinations/measurements

Group Type OTHER

blood test/ additional measurement

Intervention Type OTHER

blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation

Interventions

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blood test/ additional measurement

blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* diabetics
* patients with metastases
* other cancer
Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier DURANDO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin

Locations

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Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2011-A00206-35

Identifier Type: -

Identifier Source: org_study_id

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