Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps - Full Text View

Sponsors and Collaborators:	Dana-Farber/Brigham and Women's Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00512850

Purpose

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.

Condition	Intervention
Colorectal Cancer	Drug: folic acid Procedure: DNA methylation analysis

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Folic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Placebo Control
Official Title:	Polyp Prevention Trial

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Diagnosis of a recurrent adenomatous polyp(s) of the colorectum on subsequent colonoscopy [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:

1000

Detailed 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.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512850

Sponsors and Collaborators

Dana-Farber/Brigham and Women's Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Edward L. Giovannucci, MD, ScD

Dana-Farber/Brigham and Women's Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000559650, BWH-1999-P-001674/10, BWH-94-06819
Study First Received:	August 6, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00512850
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

colon cancer
rectal cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Polyps
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Rectal neoplasm
Folic Acid
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Vitamin B Complex
Neoplasms by Site
Hematinics
Therapeutic Uses
Growth Substances

Vitamins
Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009