Breast Cancer Clinical Trial
Reducing Breast Cancer Recurrence With Weight Loss
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.
Eligibility Criteria
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
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There are 4 Locations for this study
Birmingham Alabama, 35294, United States
La Jolla California, 92093, United States
Aurora Colorado, 80045, United States
St. Louis Missouri, 63110, United States
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