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

Overview

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).

Full Title of Study: “Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

Interventions

  • Other: Body composition measurement
    • DXA, impedance

Arms, Groups and Cohorts

  • Other: Body composition measurement
    • DXA, impedance

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference
    • Time Frame: 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
  • Evaluation of quality of life measured by Questionnaire (QLQ-C30)
    • Time Frame: After more than a year of hormonal therapy
    • Questionnaire (QLQ-C30)
  • Evaluation of the time sitting measured by Questionnaire IPAQ
    • Time Frame: After more than a year of hormonal therapy
    • Questionnaire IPAQ
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Jean Perrin
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xavier DURANDO, MD, PhD, Principal Investigator, Centre Jean Perrin

Citations Reporting on Results

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.

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