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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Body Weight Breast Cancer

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. ]

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. ]
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. ]


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)
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

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

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 May 23, 2017

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