Status:
COMPLETED
Energy Balance Interventions for Colorectal Cancer Prevention
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Obesity
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
RATIONALE: Calories and physical exercise may affect the risk of developing cancer. It is not yet known whether a low-calorie diet and/or physical activity program is effective in preventing cancer in...
Detailed Description
OBJECTIVES: * To compare four 12-week energy-balance interventions comprising a physical activity intervention (+2,000 kcal/wk), a dietary energy restriction intervention (DER)(-2,000 kcal/wk), or a ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Healthy participants at increased risk for developing colorectal cancer due to any of the following risk factors:
- Excess weight or obesity
- Body mass index 25-40 kg/m²
- Not currently exercising on a regular basis (\< 1,000 kcal/week)
- Must be free of significant eating disorders (i.e., purging, extended fasting, or use of laxatives)
- PATIENT CHARACTERISTICS:
- Females must be postmenopausal, defined by the absence of menstrual periods in the past 12 months
- No heart disease or orthopedic impairments that would limit exercise or may be worsened by exercise
- No major chronic diseases (e.g., liver, kidney, diabetes, or adrenal ailments) that would influence metabolism
- No cancer diagnoses within the past 5 years, except skin cancer
Exclusion
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00653484
Start Date
March 1 2008
End Date
June 1 2013
Last Update
December 17 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
2
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
3
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838