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Trial record 1 of 1 for:    Reducing Breast Cancer Recurrence with Weight Loss: A Vanguard Trial
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Reducing Breast Cancer Recurrence With Weight Loss (ENERGY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01112839
First Posted: April 28, 2010
Last Update Posted: June 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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: None (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 Cheryl Rock, University of California, San Diego:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Improvement in quality of life [ Time Frame: 2 years ]
  • Improvement in fatigue [ Time Frame: 2 years ]

Enrollment: 692
Study Start Date: May 2010
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: April 26, 2010
First Posted: April 28, 2010
Last Update Posted: June 18, 2015
Last Verified: June 2015

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

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