Reducing Breast Cancer Recurrence With Weight Loss

Not Applicable

Completed

• Conditions: Breast Cancer; Obesity; Overweight
• Interventions: Behavioral: Intensive Group; Behavioral: Less Intensive

• 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

Arm && Interventions

Group	Intervention	Description
Intensive Group	Intensive Group	Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
Less Intensive Group	Less Intensive	Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.

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)

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

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

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

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