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

NCT ID: NCT02509871

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-11-30

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).

Detailed Description

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Conditions

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Hormonal Therapy Breast Cancer

Keywords

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Body composition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Body composition measurement

DXA, impedance

Group Type OTHER

Body composition measurement

Intervention Type OTHER

DXA, impedance

Interventions

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Body composition measurement

DXA, impedance

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier DURANDO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin

Locations

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Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 30417829 (View on PubMed)

Other Identifiers

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2015-A00633-46

Identifier Type: -

Identifier Source: org_study_id