- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506466
Weight Variation During Chemotherapy in Breast Cancer Patients
Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- Centre Jean Perrin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- menopausal women
- breast cancer
- patients requiring chemotherapy treatment
- WHO performance status 0-2
Exclusion Criteria:
- diabetics
- patients with metastases
- other cancer
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: additional examinations/measurements
|
blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in body composition
Time Frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
|
within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in energy balance
Time Frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
|
resting energy expenditure, physical activity, food records.
|
within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
|
Change from baseline in muscle strength
Time Frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
|
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)
Time Frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
|
within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xavier DURANDO, MD, PhD, Centre Jean Perrin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-A00206-35
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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