Diet and Physical Activity in Healthy Overweight, Obese, or Inactive Participants at Risk of Developing Colorectal Cancer

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), October 2008

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00653484

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
Cancer-Related Problem/Condition Colorectal Cancer	Procedure: behavioral dietary intervention Procedure: counseling Procedure: dietary intervention Procedure: dual x-ray absorptometry Procedure: evaluation of cancer risk factors Procedure: exercise intervention Procedure: laboratory biomarker analysis Procedure: psychosocial assessment and care Procedure: questionnaire administration

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

Drug Information available for: X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label
Official Title:	Energy Balance Interventions for Colorectal Cancer Prevention

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Growth factors (i.e., fasting insulin, c-peptide, IGF-1, IGFBPs, and leptin) [ Designated as safety issue: No ]
Circulating indicators of inflammation (i.e., c-reactive protein) and oxidative stress (i.e., isoprostanes) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical activity-energy expenditure [ Designated as safety issue: No ]
Dietary-energy intake (kcal/d) and quality [ Designated as safety issue: No ]
Body weight and composition [ Designated as safety issue: No ]

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

Show Detailed Description

Eligibility

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

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

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	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Charles Matthews, PhD 615-322-4967
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Charles Matthews, PhD 615-591-9890
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Charles Matthews, PhD

Vanderbilt-Ingram Cancer Center

More Information

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

Study ID Numbers:	CDR0000592809, VU-VICC-GI-0810, VU-VICC-061020
Study First Received:	April 4, 2008
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00653484
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

colon cancer
rectal cancer
obesity

Study placed in the following topic categories:

Obesity
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Overweight
Healthy
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009