Weight Variation During Chemotherapy in Breast Cancer Patients

NCT01506466 | Completed

• 1 other identifier: 2011-A00206-35
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

chemotherapy; metabolism; weight; body composition

Outcome Measures

Primary Outcomes (1)

• Change from baseline in body composition

  within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

Secondary Outcomes (3)

• Change from baseline in energy balance

  within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

• Change from baseline in muscle strength

  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)

  within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

Study Arms (1)

additional examinations/measurements

OTHER

Other: blood test/ additional measurement

Interventions

blood test/ additional measurement OTHER

blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation

additional examinations/measurements

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• diabetics
• patients with metastases
• other cancer

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Body Weight

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Xavier DURANDO, MD, PhD

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 10, 2012
• Study Start: September 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

FR (1)