Weight Variation During Chemotherapy in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506466
• Other study ID #: 2011-A00206-35
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: July 23, 2015
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2015
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• menopausal women

• breast cancer

• patients requiring chemotherapy treatment

• WHO performance status 0-2

Exclusion Criteria:

• diabetics

• patients with metastases

• other cancer

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in body composition		within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.	No
Secondary	Change from baseline in energy balance	resting energy expenditure, physical activity, food records.	within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.	No
Secondary	Change from baseline in muscle strength		within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.	No
Secondary	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.	No