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

Not Applicable

Completed

• Conditions: Hormonal Therapy; Breast Cancer
• Interventions: Other: Body composition measurement

• Registration Number: NCT02509871
• Lead Sponsor: Centre Jean Perrin

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-28
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Body composition measurement	Body composition measurement	DXA, impedance

Primary Outcome Measures

Name	Time	Method
Measure of body composition	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

Secondary Outcome Measures

Name	Time	Method
Assessment of anxiety and depression scores measured by Questionnaire HAD	After more than a year of hormonal therapy	Questionnaire HAD
Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference	After more than a year of hormonal therapy
Evaluation of quality of life measured by Questionnaire (QLQ-C30)	After more than a year of hormonal therapy	Questionnaire (QLQ-C30)
Evaluation of the time sitting measured by Questionnaire IPAQ	After more than a year of hormonal therapy	Questionnaire IPAQ
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

Trial Locations

Locations (1)

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France