Weight Variation During Chemotherapy in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01506466|
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : July 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: blood test/ additional measurement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||January 2014|
Other: blood test/ additional measurement
blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation
- Change from baseline in body composition [ Time Frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. ]
- 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.
- Change from baseline in muscle strength [ Time Frame: 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506466
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63000|
|Principal Investigator:||Xavier DURANDO, MD, PhD||Centre Jean Perrin|