Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer
Tracking Information | |||||
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First Received Date ICMJE | November 9, 2004 | ||||
Last Updated Date | February 6, 2012 | ||||
Start Date ICMJE | September 2004 | ||||
Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
•Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related DNA endpoints [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00096330 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, single-blind study.
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 20 | ||||
Completion Date | March 2008 | ||||
Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 40 Years to 72 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00096330 | ||||
Other Study ID Numbers ICMJE | CDR0000393455, P30CA016056, RUH-PHO-0514-0404, RPCI-EPR-20703, AECM-0401022E, NEMCH-6060 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Roswell Park Cancer Institute | ||||
Study Sponsor ICMJE | Roswell Park Cancer Institute | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | Roswell Park Cancer Institute | ||||
Verification Date | February 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |