Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps
This trial is active, not recruiting.
|Condition||adenoma of large intestine|
|Treatments||folic acid, placebo|
|Sponsor||Brigham and Women's Hospital|
|Collaborator||National Cancer Institute (NCI)|
|Start date||May 1996|
|End date||March 2004|
|Trial size||672 participants|
|Trial identifier||NCT00512850, BWH-1999-P-001674/10, BWH-94-06819, CDR0000559650, R01CA067883|
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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Folic acid supplement 1g/day
Placebo pill once per day
Recurrent colorectal adenoma
time frame: May 1996-March 2004
recurrent adenoma by location, size, stage, number,
time frame: May1996-March 2004
Male or female participants up to 75 years old.
DISEASE CHARACTERISTICS: Inclusion criteria: - Participated in the Nurses' Health Study (NHS I) or the Health Professionals Follow-Up Study (HPFS) and have had a previous confirmed diagnosis of adenomatous polyp of the colon or rectum - Plan on having an endoscopy within 4 years after initiation of the trial - Must release medical records regarding past and any future endoscopies PATIENT CHARACTERISTICS: Inclusion criteria: - Plasma vitamin B12 concentration of ≥ 300 pg/mL or have a vitamin B12 concentration between 200 and 299 pg/mL and a methylmalonic acid (MMA) level ≤ 32 µg/L Exclusion criteria: - Diagnosis of cancer other than non-melanoma skin cancer, or early stage breast or prostate cancer - Diagnosis of homocystinemia - Diagnosis of pernicious anemia - Any gastrointestinal disorder that could lead to a vitamin B12 deficiency - Diagnosis of cirrhosis or pancreatitis - Diagnosis of epilepsy, Alzheimer's disease, Parkinsonism, and psychiatric disorders that may interfere with normal functioning PRIOR CONCURRENT THERAPY: Exclusion criteria: - No prior gastrectomy, total colectomy, or pancreatectomy - Other concurrent multivitamins or supplements that contain folic acid (they may take specific supplements, such as A, C, E, calcium, and iron, or antioxidant formula vitamins) - No concurrent methotrexate or anticonvulsant
|Official title||The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial|
|Principal investigator||Edward L. Giovannucci, MD, ScD|
|Description||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.|
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