Reducing Breast Cancer Recurrence With Weight Loss

Not Applicable

Completed

• Conditions: Breast Cancer; Obesity; Overweight

• Registration Number: NCT01112839
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Study Start: 2010-05
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 692

Inclusion Criteria

• Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
• BMI between 25 to 45 kg/m2
• Able to comply with all required study procedures and schedule

Exclusion Criteria

• Serious medical condition or psychiatric illness
• Inability to be moderately physically active
• Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)
• Currently enrolled in a weight loss program
• Current use of weight loss medication or supplements
• Previous surgical procedures for weight reduction
• Planning weight loss surgery in the next 2 years.
• 6+ months use of meds likely to cause weight gain or prevent weight loss
• Planned surgical procedure that can impact the conduct of the study
• Currently pregnant/breastfeeding
• Planning to become pregnant within the next 2 years
• Have plans to relocate from area within 2 years
• Family relative or close friend is a trial staff member or a study participant
• Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight loss	2 years

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life	2 years
Improvement in fatigue	2 years

Trial Locations

Locations (4)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Washington University in St. Louis: 🇺🇸 St. Louis, Missouri, United States