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

Breast Cancer Clinical Trial

— MetaCa2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509871
• Other study ID #: 2015-A00633-46
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2018
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hormonal Therapy

Intervention

Other:
• Body composition measurement
DXA, impedance

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

References & Publications (1)

Ginzac A, Thivat É, Mouret-Reynier MA, Dubray-Longeras P, Van Praagh I, Passildas J, Abrial C, Kwiatkowski F, Boirie Y, Duclos M, Morio B, Gadea É, Durando X. Weight Evolution During Endocrine Therapy for Breast Cancer in Postmenopausal Patients: Effect o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference		After more than a year of hormonal therapy
Secondary	Assessment of anxiety and depression scores measured by Questionnaire HAD	Questionnaire HAD	After more than a year of hormonal therapy
Secondary	Evaluation of quality of life measured by Questionnaire (QLQ-C30)	Questionnaire (QLQ-C30)	After more than a year of hormonal therapy
Secondary	Evaluation of the time sitting measured by Questionnaire IPAQ	Questionnaire IPAQ	After more than a year of hormonal therapy
Secondary	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