ENERGY: Reducing Breast Cancer Recurrence With Weight Loss

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT01112839

Collaborator

Washington University School of Medicine (Other), University of Colorado, Denver (Other), University of Alabama at Birmingham (Other)

692

Enrollment

Locations

Arms

57.1

Duration (Months)

173

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Overweight Obesity	Behavioral: Less Intensive Behavioral: Intensive Group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

692 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Less Intensive Group 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 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.
Experimental: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Active Comparator: Less Intensive Group

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

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.

Experimental: 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.

Behavioral: Intensive Group

Outcome Measures

Primary Outcome Measures

Weight loss [2 years]

Secondary Outcome Measures

Improvement in quality of life [2 years]
Improvement in fatigue [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3360
2	Moores UCSD Cancer Center	La Jolla	California	United States	92093
3	University of Colorado Denver	Aurora	Colorado	United States	80045
4	Washington University in St. Louis:	St. Louis	Missouri	United States	63110