- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509871
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
-
-
-
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
|
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
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.
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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University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
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