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Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00512850
First received: August 6, 2007
Last updated: December 22, 2009
Last verified: December 2009
History of Changes
  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
 Dietary Supplement: folic acid
Genetic: DNA methylation analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Polyp Prevention Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Publications:

ClinicalTrials.gov Identifier: NCT00512850     History of Changes
Other Study ID Numbers: CDR0000559650, BWH-1999-P-001674/10, BWH-94-06819
Study First Received: August 6, 2007
Last Updated: December 22, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Folic Acid
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013