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Weight Variation During Chemotherapy in Breast Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Centre Jean Perrin.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01506466
First received: January 3, 2012
Last updated: January 5, 2012
Last verified: January 2012

January 3, 2012
January 5, 2012
September 2011
June 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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
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: 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.
 
Recruiting
100
Not Provided
June 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
Female
up to 70 Years
No
France
 
NCT01506466
2011-A00206-35
No
Centre Jean Perrin
Centre Jean Perrin
Not Provided
Principal Investigator: Xavier DURANDO, MD, PhD Centre Jean Perrin
Centre Jean Perrin
January 2012

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