Reducing Breast Cancer Recurrence With Weight Loss (ENERGY)

University of California San Diego

Status: Completed

Conditions: Breast Cancer; Overweight; Obesity

Treatments: Behavioral: Less Intensive; Behavioral: Intensive Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01112839

CA148791-01

Details and patient eligibility

About

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.

Enrollment: 692 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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692 participants in 2 patient groups

Less Intensive Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Less Intensive

Intensive Group

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive Group