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Weight Variation During Chemotherapy in Breast Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506466
First Posted: January 10, 2012
Last Update Posted: July 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Jean Perrin
January 3, 2012
January 10, 2012
July 24, 2015
September 2011
March 2013   (Final data collection date for primary outcome measure)
Change from baseline in body composition [ Time Frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. ]
Same as current
Complete list of historical versions of study NCT01506466 on ClinicalTrials.gov Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Breast Cancer
Other: blood test/ additional measurement
blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation
additional examinations/measurements
Intervention: Other: blood test/ additional measurement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
January 2014
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetics
  • patients with metastases
  • other cancer
Sexes Eligible for Study: Female
up to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01506466
2011-A00206-35
No
Not Provided
Not Provided
Centre Jean Perrin
Centre Jean Perrin
Not Provided
Principal Investigator: Xavier DURANDO, MD, PhD Centre Jean Perrin
Centre Jean Perrin
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP