Energy Balance Interventions for Colorectal Cancer Prevention

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Colorectal Cancer
• Intervention / Treatment: Behavioral: Physical Activity; Behavioral: Energy Restriction; Behavioral: Physical Activity and Energy Restriction

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 combined physical activity and DER intervention (+1,000/-1,000 kcal/wk) vs no intervention in healthy, overweight, or moderately obese participants at increased risk for developing colorectal cancer.
• To quantify changes in circulating biomarkers (e.g., insulin, IGF-1, leptin, c-reactive protein, or isoprostanes) proposed to mediate the anticarcinogenic effects of DER in these participants.

OUTLINE: This study consists of a 2-week run-in period (baseline) followed by a 12-week intervention period.

Participants undergo three study visits at Vanderbilt University General Clinical Research Center (GCRC). Beginning at study visit 1, participants undergo a 2-week run-in period to obtain baseline measures of body composition (via dual x-ray absorptiometry), cardiorespiratory fitness (via treadmill testing), physical activity, dietary intake, energy expenditure, and metabolic activity. Dietary assessments using 24-hour dietary recalls are conducted by the GCRC dietitian during the run-in period. GCRC dietitians complete three 24-hour recalls on randomly selected days during the 2-week assessment period to provide an estimate of the participant's habitual food intake at baseline. Baseline energy needs are assessed during activity monitored run-in period to obtain measures of the participant's resting energy expenditure and total daily energy expenditure. Participants are also assessed using a brief psychological profile that is used to individualize the study intervention for each participant.

Approximately 10-14 days after the initial visit and after all baseline assessments have been completed, participants undergo a second study visit. Participants are randomized to 1 of 4 intervention arms.

• Arm I (physical activity): Participants undergo an in-person, 30- to 60-minute counseling visit, followed by five brief 10- to 15-minute telephone-counseling calls over 12 weeks. During the initial counseling session, participants learn about goal setting and how to develop a personalized plan for meeting their intervention goals. Participants are instructed about wearing proper shoes and about monitoring their exercise duration and intensity. Participants are also given pedometers to help track their activity patterns and to monitor their progress in meeting program objectives. Participants must wear the pedometers for 7 days at baseline and again at 12 weeks. The information provided is used to estimate overall physical activity energy expenditure (PAEE), steps per day, and time spent in different levels of activity.

Participants are monitored periodically for adherence to the exercise program through behavioral counseling and self-reported logs of daily exercise and pedometer steps. Dietary intake is measured periodically using multiple 24-hour dietary recalls to carefully assess possible changes in energy intake and dietary quality over the course of the study.

• Arm II (dietary energy restriction [DER]): Based on the initial estimate of energy needs determined during the run-in period, participants receive a reduced-calorie, food exchange-based diet for 12 weeks. Each diet is individualized to achieve the desired daily energy deficit of 300 calories per day based on physical activity levels. All meals are prepared by the GCRC metabolic kitchen. Participants receive one multivitamin per day and no other nutritional supplements. Fluids including coffee, water, and other drinks are allowed at the pre-study level. Each week, participants meet with the dietitian to discuss the participant's progress, submit daily reports of food intake, return uneaten food items, and to provide urine samples for assessment of urinary biomarkers.

Adherence to the diet is monitored by compliance with food pick-up, dietary records, and measures of urinary metabolites. Participants are also provided with individual instruction, counseling, and assessment by the study dietitian.

• Arm III (physical activity and DER): Participants undergo a 12-week DER and physical-activity program, as described in arms I and II, with the exception that the dose of PAEE and DER in the combined intervention (i.e., +1,000/-1,000 kcal/week) is half that of each individual intervention (+2,000 kcal/week for arm I and -2,000 kcal/week for arm II). Participants in arm III receive an individualized reduced-calorie diet designed to achieve a desired daily energy deficit of 150 calories per day based on participant physical activity levels.
• Arm IV (wait-list control): Participants are followed periodically. At study visit 3, after completion of the 12-week study interventions, participants undergo repeat assessment of body composition, fitness, diet, and activity measures.

Participants undergo blood and urine sample collection at baseline and at 12 weeks for correlative laboratory studies. Blood samples are assessed for circulating biomarkers that are involved in energy homeostasis and metabolic control (e.g., insulin, IGF, and leptin) and inflammation and oxidative stress (e.g., c-reactive protein, PGE-2, and isoprostanes). Urine samples are examined for biomarkers of dietary protein intake (i.e., nitrogen content), dietary sodium, and potassium intake.

Participants complete the Community Health Activities Model Program for Seniors Physical Activity Questionnaire at baseline and at 12 weeks for assessment of PAEE through non-occupational activities, including social activities, recreation, hobbies, housework, walking, jogging, and 14 other types of exercise.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity Only; Physical Activity	Behavioral: Physical Activity
Experimental: Dietary Energy Restriction; Energy restriction	Behavioral: Energy Restriction
Experimental: Physical Activity+Dietary Energy Restriction; Physical Activity ad Energy Restriction	Behavioral: Physical Activity and Energy Restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical activity-energy expenditure	June 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
Physical activity-energy expenditure	June 2010
Dietary-energy intake (kcal/d) and quality	June 2010
Body weight and composition	June 2010

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Charles Matthews, PhD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: obesity; rectal cancer; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDR0000592809; VU-VICC-GI-0810; VU-VICC-061020