Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2) (MetaCa2)
Primary Purpose
Hormonal Therapy, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Body composition measurement
Sponsored by
About this trial
This is an interventional basic science trial for Hormonal Therapy focused on measuring Body composition
Eligibility Criteria
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
Sites / Locations
- Centre Jean Perrin
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Body composition measurement
Arm Description
DXA, impedance
Outcomes
Primary Outcome Measures
Measure of body composition
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
Secondary Outcome Measures
Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference
Assessment of anxiety and depression scores measured by Questionnaire HAD
Questionnaire HAD
Evaluation of quality of life measured by Questionnaire (QLQ-C30)
Questionnaire (QLQ-C30)
Evaluation of the time sitting measured by Questionnaire IPAQ
Questionnaire IPAQ
Evaluate the change in body composition longitudinally from the data of the study Metaca
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02509871
Brief Title
Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2)
Acronym
MetaCa2
Official Title
Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormonal Therapy, Breast Cancer
Keywords
Body composition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body composition measurement
Arm Type
Other
Arm Description
DXA, impedance
Intervention Type
Other
Intervention Name(s)
Body composition measurement
Intervention Description
DXA, impedance
Primary Outcome Measure Information:
Title
Measure of body composition
Description
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
Time Frame
After more than a year of hormonal therapy
Secondary Outcome Measure Information:
Title
Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference
Time Frame
After more than a year of hormonal therapy
Title
Assessment of anxiety and depression scores measured by Questionnaire HAD
Description
Questionnaire HAD
Time Frame
After more than a year of hormonal therapy
Title
Evaluation of quality of life measured by Questionnaire (QLQ-C30)
Description
Questionnaire (QLQ-C30)
Time Frame
After more than a year of hormonal therapy
Title
Evaluation of the time sitting measured by Questionnaire IPAQ
Description
Questionnaire IPAQ
Time Frame
After more than a year of hormonal therapy
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, MD, PhD
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30417829
Citation
Ginzac A, Thivat E, Mouret-Reynier MA, Dubray-Longeras P, Van Praagh I, Passildas J, Abrial C, Kwiatkowski F, Boirie Y, Duclos M, Morio B, Gadea E, Durando X. Weight Evolution During Endocrine Therapy for Breast Cancer in Postmenopausal Patients: Effect of Initial Fat Mass Percentage and Previous Adjuvant Treatments. Clin Breast Cancer. 2018 Oct;18(5):e1093-e1102. doi: 10.1016/j.clbc.2018.06.010. Epub 2018 Jun 18.
Results Reference
result
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Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2)
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