NCT02509871

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

July 23, 2015

Last Update Submit

December 17, 2018

Conditions

Hormonal TherapyBreast Cancer

Keywords

Body composition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    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

  • Evaluation of the time sitting measured by 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

Study Arms (1)

Body composition measurement

OTHER

DXA, impedance

Other: Body composition measurement

Interventions

Body composition measurementOTHER

DXA, impedance

Body composition measurement

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Related Publications (1)

  • 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.

    PMID: 30417829RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xavier DURANDO, MD, PhD

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 28, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations

FR(1)