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

Study Overview
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Brief Summary
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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).

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

Conditions
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Hormonal Therapy, Breast Cancer

Intervention / Treatment
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* Other: Body composition measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Body composition measurement<br>DXA, impedance | Other: Body composition measurement<br>* DXA, impedance<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body composition