Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Dietary Supplement: vitamin EOther: laboratory biomarker analysis
- Registration Number
- NCT00905918
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
RATIONALE: Vitamin E may help prevent the development of cancer. Studying samples of tissue from patients with colorectal cancer who receive Vitamin E before undergoing surgery in the laboratory may help doctors learn more about how Vitamin E changes biomarkers related to colorectal cancer.
PURPOSE: This randomized early phase I trial is studying giving vitamin E supplements to see how it affects biomarkers in patients undergoing surgery for colorectal cancer.
- Detailed Description
OBJECTIVES:
* Determine the effect of high γ-tocopherol vitamin E mixture supplementation on plasma levels of α-, γ-, and δ-tocopherols, and prostaglandin E_2 in patients planning to undergo surgery for colorectal cancer by comparing the blood samples collected before and after the supplementation in each of the groups and analyzing levels of tocopherols and their metabolites in urine samples.
* Test the hypothesis that the supplementation reduces oxidative and nitrosative stress by measuring plasma levels of F_2-isoprostane, C-reactive protein, and 3-nitrotyrosine as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG).
* Determine the levels of α-, γ-, and δ-tocopherols in colon tissues and analyze immunohistochemically for cell proliferation, apoptosis, β-catenin localization, RXR expression, cyclooxygenase-2, 8-OHdG, and 3-nitrotyrosine levels in colon cancer tissue slides.
OUTLINE: This is a multicenter study. The first 5 patients receive no supplements (to establish laboratory standards), all other patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive no intervention before undergoing planned surgery.
* Arm II: Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery.
* Arm III: Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.
Blood and urine samples are collected at baseline and on the day of surgery for tocopherol and biomarker analysis. A sample of colon tissue is removed during standard surgical resection for chemical analysis. Plasma, tumor tissue, and nontumorous tissues are analyzed for levels of F_2-isoprostane, 8-OHdG, 3-nitrotyrosine, and prostaglandin E_2 via enzyme immunoassays and for levels of α-, γ-, and δ-tocopherols via HPLC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm III laboratory biomarker analysis Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery. Arm II laboratory biomarker analysis Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery. Arm II vitamin E Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery. Arm III vitamin E Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.
- Primary Outcome Measures
Name Time Method Presence in colon tissue of α-, γ-, and δ-tocopherols, cell proliferation and apoptosis indicators, β-catenin localization, RXR expression, and cyclooxygenase-2, 8-OHdG, and 3-nitrotyrosine levels 4 years Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2 4 years Plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine and urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG) 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States