Reducing Breast Cancer Recurrence With Weight Loss (ENERGY)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Washington University School of Medicine
University of Colorado, Denver
University of Alabama at Birmingham
Information provided by (Responsible Party):
Cheryl Rock, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01112839
First received: April 26, 2010
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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 Intervention
Breast Cancer
Overweight
Obesity
Behavioral: Less Intensive
Behavioral: Intensive Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement in fatigue [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: May 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112839

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3360
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Missouri
Washington University in St. Louis:
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
University of California, San Diego
Washington University School of Medicine
University of Colorado, Denver
University of Alabama at Birmingham
Investigators
Principal Investigator: Cheryl L. Rock, PhD, RD University of California, San Diego
  More Information

No publications provided

Responsible Party: Cheryl Rock, Study Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01112839     History of Changes
Other Study ID Numbers: CA148791-01
Study First Received: April 26, 2010
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Overweight
Obese
Breast cancer survivors
Weight loss
Exercise
Physical activity

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Recurrence
Weight Loss
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Disease Attributes
Pathologic Processes
Body Weight Changes

ClinicalTrials.gov processed this record on July 26, 2014