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N/A N=120 Randomized Prevention

Healthy Eating for Colon Cancer Prevention

Colon Cancer

Enrolled (actual)
120
Serious AEs
1.7%
Results posted
Jul 2015
Primary outcome: Primary: Adherence to Dietary Goals — 89; 85 percentage of participants meeting goals

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
1 Healthy Eating (Behavioral); 2 Mediterranean (Behavioral)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Nov 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Adherence to Dietary Goals
89; 85

Summary

The purpose of this study is to help develop diets for colon cancer prevention. This study will compare the Mediterranean diet to the Healthy People 2010 diet in 120 subjects with increased risk for colorectal cancer.

Eligibility Criteria

Inclusion Criteria

  • Prior adenomatous polyp.
  • Prior resected early (Dukes A, B, or C) colon cancer. With the exception of curative surgery for small lesions, such as endoscopically removed cancers, eligible subject will be at least two years post treatment for colorectal cancer.
  • A history of colon cancer in a primary relative or in two secondary relatives.
  • Good general health and not expecting major lifestyle changes in the next 6 months.
  • Age 21 or older.
  • Not expecting a change in hormonal therapies over the next 6 months.
  • Taking less than 81 mg/day or 325 mg aspirin every other day for prevention of cardiovascular disease.
  • Dietary intake that is within the usual range for a typical American diet.
  • Read and understand English.
  • Sign the consent and willing to comply with all study procedures.
  • Have a telephone.
  • At least 5 years post any type of treatment for any other cancer except cancers that were removed completely by surgery and no other treatment was undergone.
  • No more than occasional use ( 35 kg/m2 since low BMI could indicate eating disorders and high BMI values, above the midpoint of the obesity range, could indicate more prevalent health problems and these persons can be more difficult to counsel.
  • Persons taking very high levels of aspirin or non-steroidal anti-inflammatory agents (NSAIDS) for conditions such as arthritis, a chronic inflammatory condition, will be excluded since it will preclude our ability to detect a further decrease in PGE2.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00475722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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