Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00096330|
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : January 13, 2014
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Dietary Supplement: dietary intervention Dietary Supplement: folic acid||Phase 1|
- 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.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Study of Folate|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||March 2008|
Dietary Supplement: dietary intervention
- •Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related DNA endpoints [ Time Frame: pre and post treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096330
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||James Marshall, PhD||Roswell Park Cancer Institute|