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Weight Variation During Chemotherapy in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01506466
First received: January 3, 2012
Last updated: July 23, 2015
Last verified: July 2015
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Other: blood test/ additional measurement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 52
Study Start Date: September 2011
Study Completion Date: January 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
additional examinations/measurements Other: blood test/ additional measurement
blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation

  Eligibility
Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01506466     History of Changes
Other Study ID Numbers: 2011-A00206-35 
Study First Received: January 3, 2012
Last Updated: July 23, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 23, 2016