Weight Variation During Chemotherapy in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: blood test/ additional measurement

• Registration Number: NCT01506466
• Lead Sponsor: Centre Jean Perrin

Brief Summary

Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.

Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-10
• Primary Completion: 2013-03
• Study Completion: 2014-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• menopausal women
• breast cancer
• patients requiring chemotherapy treatment
• WHO performance status 0-2

Exclusion Criteria

• diabetics
• patients with metastases
• other cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
additional examinations/measurements	blood test/ additional measurement	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in body composition	within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in energy balance	within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.	resting energy expenditure, physical activity, food records.
Change from baseline in muscle strength	within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors)	within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

Trial Locations

Locations (1)

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France