Reducing Breast Cancer Recurrence With Weight Loss

Breast Cancer Clinical Trial

— ENERGY  

Official title:

Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112839
• Other study ID #: CA148791-01
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: June 17, 2015
• Start date: May 2010
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity
• Overweight
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Washington University in St. Louis:	St. Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Diego	University of Alabama at Birmingham, University of Colorado, Denver, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		2 years	No
Secondary	Improvement in quality of life		2 years	No
Secondary	Improvement in fatigue		2 years	No