Reducing Breast Cancer Recurrence With Weight Loss
ENERGY
1 other identifier
interventional
692
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started May 2010
Typical duration for not_applicable breast-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJune 18, 2015
June 1, 2015
4.8 years
April 26, 2010
June 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss
2 years
Secondary Outcomes (2)
Improvement in quality of life
2 years
Improvement in fatigue
2 years
Study Arms (2)
Less Intensive Group
ACTIVE COMPARATORParticipants 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.
Intensive Group
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
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.
- + 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- Washington University School of Medicinecollaborator
- University of Colorado, Denvercollaborator
- University of Alabama at Birminghamcollaborator
Study Sites (4)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3360, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Washington University in St. Louis:
St Louis, Missouri, 63110, United States
Related Publications (2)
Kenzik KM, Demark-Wahnefried W, Ganz PA, Colditz G, Rock CL, Rogers LQ. Changes in Body Mass Index and Physical Activity Predict Changes in Vitality During a Weight Loss Trial in Breast Cancer Survivors. Ann Behav Med. 2018 Nov 12;52(12):999-1009. doi: 10.1093/abm/kay004.
PMID: 29617707DERIVEDRock CL, Flatt SW, Byers TE, Colditz GA, Demark-Wahnefried W, Ganz PA, Wolin KY, Elias A, Krontiras H, Liu J, Naughton M, Pakiz B, Parker BA, Sedjo RL, Wyatt H. Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors. J Clin Oncol. 2015 Oct 1;33(28):3169-76. doi: 10.1200/JCO.2015.61.1095. Epub 2015 Aug 17.
PMID: 26282657DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl L. Rock, PhD, RD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
April 26, 2010
First Posted
April 28, 2010
Study Start
May 1, 2010
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
June 18, 2015
Record last verified: 2015-06