Reducing Breast Cancer Recurrence With Weight Loss

Completed · Not applicable

Conditions studied: Breast Cancer, Overweight, Obesity

In brief

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.

Key facts

Study ID

NCT01112839

Run by

University of California, San Diego

People needed

692

Starts

2010-05-01

Expected to finish

2015-02-01

Last updated by the study team

2015-06-18

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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