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Reducing Breast Cancer Recurrence With Weight Loss (ENERGY)

Primary Purpose

Breast Cancer, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Less Intensive
Intensive Group
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Overweight, Obese, Breast cancer survivors, Weight loss, Exercise, Physical activity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University of Alabama at Birmingham
  • Moores UCSD Cancer Center
  • University of Colorado Denver
  • Washington University in St. Louis:

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Less Intensive Group

Intensive Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Improvement in quality of life
Improvement in fatigue

Full Information

First Posted
April 26, 2010
Last Updated
June 17, 2015
Sponsor
University of California, San Diego
Collaborators
Washington University School of Medicine, University of Colorado, Denver, University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01112839
Brief Title
Reducing Breast Cancer Recurrence With Weight Loss
Acronym
ENERGY
Official Title
Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Washington University School of Medicine, University of Colorado, Denver, University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Overweight, Obesity
Keywords
Overweight, Obese, Breast cancer survivors, Weight loss, Exercise, Physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
692 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Less Intensive Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Intensive Group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Less Intensive
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Group
Intervention 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.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Time Frame
2 years
Title
Improvement in fatigue
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl L. Rock, PhD, RD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3360
Country
United States
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Washington University in St. Louis:
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29617707
Citation
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.
Results Reference
derived
PubMed Identifier
26282657
Citation
Rock 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.
Results Reference
derived

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Reducing Breast Cancer Recurrence With Weight Loss

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