Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps
Recruitment status was Active, not recruiting
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The use of folic acid may prevent colorectal cancer.
PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.
Dietary Supplement: folic acid
Genetic: DNA methylation analysis
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||Polyp Prevention Trial|
- Diagnosis of a recurrent adenomatous polyp(s) of the colorectum on subsequent colonoscopy [ Designated as safety issue: No ]
- Number of adenomas per patient and the size and histology of these adenomas [ Designated as safety issue: No ]
- Interaction between folic acid intake and alcohol, methionine, and aspirin intake [ Designated as safety issue: No ]
- Determine if folic acid supplementation lowers the adenoma recurrence rate.
- Determine the number of adenomas per patient and the size and histology of the adenoma.
- Assess the interaction between folic acid and alcohol, methionine, and aspirin intake.
- Assess the interaction between folic acid and pretrial and midtrial folate levels.
- Assess other complementary biomarkers such as DNA methylation and blood folate level as risk factors for polyp recurrence.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral folic acid once daily.
- Arm II: Patients receive oral placebo once daily. At least 1 year after beginning treatment, patients are sent a blood collection kit in order to measure plasma vitamin B12 levels, to measure folate to assess compliance.
|Principal Investigator:||Edward L. Giovannucci, MD, ScD||Dana-Farber/Brigham and Women's Cancer Center|