Reducing Breast Cancer Recurrence With Weight Loss (ENERGY)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of California, San Diego.
Recruitment status was  Active, not recruiting
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

April 26, 2010
August 8, 2012
May 2010
April 2013   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01112839 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Reducing Breast Cancer Recurrence With Weight Loss
Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Breast Cancer
  • Overweight
  • Obesity
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Less Intensive
  • 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.
    Intervention: Behavioral: Intensive Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
April 2014
April 2013   (final data collection date for primary outcome measure)

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
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01112839
CA148791-01
Yes
Cheryl Rock, University of California, San Diego
University of California, San Diego
  • Washington University School of Medicine
  • University of Colorado, Denver
  • University of Alabama at Birmingham
Principal Investigator: Cheryl L. Rock, PhD, RD University of California, San Diego
University of California, San Diego
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP