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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
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: blood test/ additional measurement Not Applicable

Study Design
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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

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
additional examinations/measurements Other: blood test/ additional measurement
blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in body composition [ Time Frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. ]

Secondary Outcome Measures :
  1. 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.

  2. Change from baseline in muscle strength [ Time Frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. ]
  3. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetics
  • patients with metastases
  • other cancer
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Locations
France
Centre Jean Perrin
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Centre Jean Perrin
Investigators
Principal Investigator: Xavier DURANDO, MD, PhD Centre Jean Perrin
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01506466     History of Changes
Other Study ID Numbers: 2011-A00206-35
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Centre Jean Perrin:
chemotherapy
metabolism
weight
body composition

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases