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Clinical Trials/NCT01112839
NCT01112839
Completed
Not Applicable

Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial

University of California, San Diego4 sites in 1 country692 target enrollmentMay 2010
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ConditionsBreast CancerOverweightObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of California, San Diego
Enrollment
692
Locations
4
Primary Endpoint
Weight loss
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cheryl Rock

Study Principal Investigator

University of California, San Diego

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

Outcomes

Primary Outcomes

Weight loss

Time Frame: 2 years

Secondary Outcomes

  • Improvement in fatigue(2 years)
  • Improvement in quality of life(2 years)

Study Sites (4)

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