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Completed

NCT Number: NCT01112839

Reducing Breast Cancer Recurrence With Weight Loss

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.

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Key information

Conditions

Breast Cancer Behavior Body Weight Body Weight Changes Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Weight Loss

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Less Intensive

Behavioral

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.

Intensive Group

Behavioral

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 outcomes

  1. Weight loss

    Time frame: 2 years

Secondary outcomes

  1. Improvement in quality of life

    Time frame: 2 years

  2. Improvement in fatigue

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • University of Alabama at Birmingham
  • University of Colorado, Denver
  • Washington University School of Medicine

Registry information

Official study title

Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial

Acronym: ENERGY

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2010
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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