Effect of Diet and Exercise in Breast Cancer Survivors

Breast Cancer Clinical Trial

— F4F tri neg  

Official title:

Fit for the Fight: Effect of a Multidisciplinary Diet and Exercise Program on Body Weight, Quality of Life and Inflammation in Survivors of Triple-negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498536
• Other study ID #: H-22426
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: October 29, 2013
• Start date: July 2011
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ER/PR/HER2neu negative breast cancer

• at least 3 months after end of treatment

• BMI at least 25

Exclusion Criteria:

• stage IV cancer

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity

Intervention

Behavioral:
• aerobic exercise
3 times per week for 12-weeks

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	aim for loss of 10% of BMI	12 weeks	No
Primary	quality of life	Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires	12 weeks	No
Secondary	markers of inflammation	blood draws at beginning and end of study to analyze any effect on inflammation	12 weeks	No