Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2) (MetaCa2)

December 17, 2018 updated by: Centre Jean Perrin

Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer

This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean PERRIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postmenopausal women
  • patients requiring hormonal treatment
  • WHO performance status 0-2
  • patients initially included in MetaCa (AU882) protocol
  • Affiliation to a social security scheme (or be the beneficiary of such a plan)
  • patients who signed the informed consent form

Exclusion Criteria:

  • patients witg relapse, with metastases or other cancer
  • concurrent treatment with a drug test, or participation in a clinical trial within < 30 days
  • patients carrying an electronic medical device (eg pacemaker)
  • patients who refused to sign the consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Body composition measurement
DXA, impedance
Other: Body composition measurement
DXA, impedance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of body composition
Time Frame: After more than a year of hormonal therapy
To obtain additional data to those of Metaca study (AU882) to assess changes in body composition (fat mass, lean body mass in Kg) in women with breast cancer and treated with adjuvant hormonal therapy following chemotherapy
After more than a year of hormonal therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference
Time Frame: After more than a year of hormonal therapy
After more than a year of hormonal therapy
Assessment of anxiety and depression scores measured by Questionnaire HAD
Time Frame: After more than a year of hormonal therapy
Questionnaire HAD
After more than a year of hormonal therapy
Evaluation of quality of life measured by Questionnaire (QLQ-C30)
Time Frame: After more than a year of hormonal therapy
Questionnaire (QLQ-C30)
After more than a year of hormonal therapy
Evaluation of the time sitting measured by Questionnaire IPAQ
Time Frame: After more than a year of hormonal therapy
Questionnaire IPAQ
After more than a year of hormonal therapy
Evaluate the change in body composition longitudinally from the data of the study Metaca
Time Frame: Between after 1 and 6 months after chemotherapy and after more than a year of hormonal therapy
Between after 1 and 6 months after chemotherapy and after more than a year of hormonal therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Investigators

  • Principal Investigator: Xavier DURANDO, MD, PhD, Centre Jean PERRIN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00633-46

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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