Adenoma of Large Intestine Clinical Trial
Official title:
The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial
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.
OBJECTIVES:
Primary
- Determine if folic acid supplementation lowers the adenoma recurrence rate.
Secondary
- 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01925833 -
Adenoma Detection by Polypectomy During Both Insertion and Withdrawal
|
N/A |