Energy Balance Interventions for Colorectal Cancer Prevention - Full Text View

Purpose

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 participants at increased risk of developing colorectal cancer.

PURPOSE: This randomized clinical trial is studying diet and physical activity in healthy overweight, obese, or inactive participants at risk of developing colorectal cancer.

Condition	Intervention
Colorectal Cancer Obesity	Behavioral: behavioral dietary intervention Behavioral: exercise intervention Dietary Supplement: dietary intervention Other: counseling intervention Other: laboratory biomarker analysis Other: questionnaire administration Procedure: dual x-ray absorptometry Procedure: evaluation of cancer risk factors Procedure: psychosocial assessment and care

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Energy Balance Interventions for Colorectal Cancer Prevention

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Diabetes Medicines Exercise and Physical Fitness Obesity

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Growth factors (i.e., fasting insulin, c-peptide, IGF-1, IGFBPs, and leptin) [ Time Frame: Not specified ] [ Designated as safety issue: No ]
Circulating indicators of inflammation (i.e., c-reactive protein) and oxidative stress (i.e., isoprostanes) [ Time Frame: Not specified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical activity-energy expenditure [ Time Frame: Not specified ] [ Designated as safety issue: No ]
Dietary-energy intake (kcal/d) and quality [ Time Frame: not specified ] [ Designated as safety issue: No ]
Body weight and composition [ Time Frame: Not specified ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2013
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Physical Activity Only	Behavioral: behavioral dietary intervention None noted Other Name: Not specified Behavioral: exercise intervention not noted Other Name: not specified Dietary Supplement: dietary intervention none noted Other Name: not specified Other: counseling intervention not noted Other Name: not specified Other: laboratory biomarker analysis not noted Other Name: not specified Other: questionnaire administration none noted Other Name: not specified Procedure: dual x-ray absorptometry not noted Other Name: not specified Procedure: evaluation of cancer risk factors not noted Other Name: not specified Procedure: psychosocial assessment and care not noted Other Name: not specified
No Intervention: Dietary Energy Restriction	Behavioral: behavioral dietary intervention None noted Other Name: Not specified Behavioral: exercise intervention not noted Other Name: not specified Dietary Supplement: dietary intervention none noted Other Name: not specified Other: counseling intervention not noted Other Name: not specified Other: laboratory biomarker analysis not noted Other Name: not specified Other: questionnaire administration none noted Other Name: not specified Procedure: dual x-ray absorptometry not noted Other Name: not specified Procedure: evaluation of cancer risk factors not noted Other Name: not specified Procedure: psychosocial assessment and care not noted Other Name: not specified
No Intervention: Combined Physical Activity/Dietary Energy Restriction	Behavioral: behavioral dietary intervention None noted Other Name: Not specified Behavioral: exercise intervention not noted Other Name: not specified Dietary Supplement: dietary intervention none noted Other Name: not specified Other: counseling intervention not noted Other Name: not specified Other: laboratory biomarker analysis not noted Other Name: not specified Other: questionnaire administration none noted Other Name: not specified Procedure: dual x-ray absorptometry not noted Other Name: not specified Procedure: evaluation of cancer risk factors not noted Other Name: not specified Procedure: psychosocial assessment and care not noted Other Name: not specified
No Intervention: Wait-List Control	Behavioral: behavioral dietary intervention None noted Other Name: Not specified Behavioral: exercise intervention not noted Other Name: not specified Dietary Supplement: dietary intervention none noted Other Name: not specified Other: counseling intervention not noted Other Name: not specified Other: laboratory biomarker analysis not noted Other Name: not specified Other: questionnaire administration none noted Other Name: not specified Procedure: dual x-ray absorptometry not noted Other Name: not specified Procedure: evaluation of cancer risk factors not noted Other Name: not specified Procedure: psychosocial assessment and care not noted Other Name: not specified

Show Detailed Description

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653484

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838

Sponsors and Collaborators

Vanderbilt University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Charles Matthews, PhD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Charles Matthews, PHD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00653484 History of Changes
Other Study ID Numbers:	CDR0000592809, VU-VICC-GI-0810, VU-VICC-061020
Study First Received:	April 4, 2008
Last Updated:	December 16, 2010
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt University:

colon cancer
rectal cancer
obesity

Additional relevant MeSH terms:

Colorectal Neoplasms
Obesity
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Colonic Diseases
Intestinal Diseases
Rectal Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013