Reducing Breast Cancer Recurrence With Weight Loss

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial

Conditions
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Breast Cancer, Overweight, Obesity

Intervention / Treatment
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* Behavioral: Less Intensive
* Behavioral: Intensive Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Less Intensive Group<br>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. | Behavioral: Less Intensive<br>* 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.<br>|
| Experimental: Intensive Group<br>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. | Behavioral: Intensive Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life |  | 2 years | 
| Improvement in fatigue |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obese, Breast cancer survivors, Weight loss, Exercise, Physical activity