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

Tracking Information
First Submitted Date ICMJE	November 9, 2004
First Posted Date ICMJE	November 9, 2004
Last Update Posted Date	January 13, 2014
Study Start Date ICMJE	September 2004
Actual Primary Completion Date	February 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 6, 2012)	•Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related DNA endpoints [ Time Frame: pre and post treatment ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00096330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer
Official Title ICMJE	Phase I Clinical Study of Folate
Brief Summary	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.
Detailed Description	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.; Randomization: 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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Colorectal Cancer
Intervention ICMJE	Dietary Supplement: dietary intervention oral folic acid supplementation once daily on days 57-84; Dietary Supplement: folic acid oral folic acid supplementation once daily on days 1-56.
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 8, 2006)	20
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	March 2008
Actual Primary Completion Date	February 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Healthy persons at increased risk for colorectal neoplasia due to 1 of the following reasons: Personal history of colorectal adenomatous polyps Family history of colorectal adenoma or adenocarcinoma; No history of multiple family members with colorectal neoplasia that is suggestive of dominant hereditary neoplasia 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 Chemotherapy 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 Surgery; No prior gastrointestinal surgery, including gastrectomy or small or large bowel resections Prior appendectomy or surgery of the esophagus allowed 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 Simvastatin 5 or 10 mg/day
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years to 72 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00096330
Other Study ID Numbers ICMJE	CDR0000393455; P30CA016056 ( U.S. NIH Grant/Contract ); RUH-PHO-0514-0404; RPCI-EPR-20703; AECM-0401022E; NEMCH-6060
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Roswell Park Cancer Institute
Study Sponsor ICMJE	Roswell Park Cancer Institute
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: James Marshall, PhD Roswell Park Cancer Institute
PRS Account	Roswell Park Cancer Institute
Verification Date	January 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP