Clinical Trial: Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Rockefeller University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Chemoprevention therapy is the use of certain agents to try to prevent the development of cancer. The use of folic acid may be effective in preventing colorectal cancer. Eating a diet rich in folic acid may prevent the development of colorectal cancer.

PURPOSE: This randomized phase I trial is studying how well a folate-depleted diet works compared to a folate-supplemented diet in preventing colorectal cancer in patients who are at high risk for developing colorectal cancer.

Condition Treatment or Intervention Phase
Colon Cancer
Rectal Cancer
 Drug: folic acid
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer
 Procedure: complementary and alternative therapy
 Procedure: dietary intervention
 Procedure: dietary modification
 Procedure: nutritional supplementation
Phase I

MedlinePlus related topics:  Colorectal Cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Phase I Randomized Study of Folate-Depleted Versus Folate-Supplemented Diet for the Prevention of Colorectal Cancer in Patients at High Risk for Colorectal Neoplasia

Further Study Details: 

OBJECTIVES: Primary

  • Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related DNA endpoints (e.g., genomic and gene-specific DNA methylation and DNA strand breaks) in rectal epithelial cells in patients at high risk for colorectal neoplasia.
  • Analyze the effects of these dietary interventions on folate-related DNA endpoints (e.g., genomic and gene-specific DNA methylation, DNA strand breaks, and uracil incorporation into DNA) in blood mononuclear cells in these patients.

Secondary

  • Analyze the effects of these dietary interventions on the patterns of differential gene expression in rectal epithelial cells and blood mononuclear cells in these patients.

OUTLINE: This is a randomized, single-blind study.

  • Run-in period: Patients are placed on an average folate-containing diet for 56 days.
  • After completion of the run-in period, patients are randomized to 1 of 2 arms.
  • Arm I (folate depleted diet): Patients are placed on a low-folate diet for 84 days. Patients receive oral folic acid supplementation once daily on days 57-84.
  • Arm II (folate supplemented diet): Patients continue on an average folate-containing diet for an additional 56 days. Patients receive oral folic acid supplementation once daily on days 1-56. Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 20 patients (10 per arm) will be accrued for this study within 2.5 years.

Eligibility

Ages Eligible for Study:  40 Years   -   72 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 40 to 72

Performance status

  • Ambulatory

Life expectancy

  • At least 6 months

Hematopoietic

  • No excessive bleeding or coagulation disorder

Hepatic

  • ALT or AST ≤ 2 times upper limit of normal
  • No unexplained elevated alkaline phosphatase

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • Homocysteine concentration ≤ 17um/L
  • No sustained blood pressure > 150/95 mm Hg for 3 consecutive readings

Other

  • Vitamin B_12 ≥ 250 pg/mL
  • Folate level ≤ 20 mg/dL
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No intestinal malabsorption or inflammatory bowel disease
  • No prior malignancy except nonmelanoma skin cancer
  • No calcium metabolism abnormalities or predisposing conditions, such as hyperparathyroidism
  • No untreated hyperthyroidism
  • No untreated insulin-requiring diabetes mellitus
  • No daily alcohol intake > 2 ½ shot glasses of whiskey or three 8 ounce glasses of beer or wine
  • No other serious illness that might limit life expectancy to < 6 months

PRIOR CONCURRENT THERAPY: Biologic therapy

  • None

Chemotherapy

  • None

Endocrine therapy

  • No concurrent hormone replacement therapy, including oral, transplanted, or injected contraceptives
  • Concurrent thyroid hormone replacement is allowed as long as the patient is euthyroid for 3 months

Radiotherapy

  • None

Surgery

Other

  • More than 3 months since regular ingestion of ≥ 650 mg per day of aspirin (≥ 2 tablets of 325 mg regular strength OR > 1 tablet of 500 mg extra strength aspirin)
  • More than 3 months since regular daily ingestion of nonsteroidal anti-inflammatory drugs
  • At least 1 month since vitamin, mineral, or herbal supplementation
  • No other concurrent vitamin, mineral, or herbal supplementation
  • No concurrent anticoagulants
  • No concurrent sterol-binding resins (i.e., cholestyramine)
  • No other concurrent investigational drugs or medications that might alter rectal mucosal proliferation, folate metabolism, or renal/hepatic impairment
  • No concurrent weight control medications
  • No concurrent supplemental folate preparations containing > 400 mcg of folic acid per day
  • No concurrent lipid-lowering medications
  • The following concurrent statin drugs are allowed provided patient has been taking a stable dose for ≥ 1 month:
  • Atorvastatin 10 or 20 mg/day
  • Fluvastatin 20 or 40 mg/day
  • Lovastatin 10 or 20 mg/day
  • Pravastatin 10 or 20 mg/day
  • Simivastatin 5 or 10 mg/day

Location and Contact Information


Massachusetts
      Cancer Center at Tufts - New England Medical Center, Boston,  Massachusetts,  02111-1854,  United States; Recruiting
Joel Mason, MD  617-556-3194 

New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States; Recruiting
Leonard H. Augenlicht, PhD  718-920-4663 

      Rockefeller University Hospital, New York,  New York,  10021-6399,  United States; Recruiting
Peter R. Holt, MD  212-734-0567 ext. 207    pholt@chpnet.org 

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-001,  United States; Recruiting
Jim Marshall, PhD  716-845-8444 

      Strang Cancer Prevention Center, New York,  New York,  10021-6399,  United States; Recruiting
Martin Lipkin, MD  212-734-0567 ext. 206 

Study chairs or principal investigators

Jim Marshall, PhD,  Principal Investigator,  Roswell Park Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000393455; RUH-PHO-0514-0404; RPCI-EPR-20703; AECM-0401022E; NEMCH-6060; NCT00096330
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00096330
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005