Colon Cancer Clinical Trial
Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer
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.
Full 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Suspected or confirmed colorectal cancer meeting the following criteria:
Scheduled for surgery as the initial treatment
Referred to the Cancer Institute of New Jersey or the Robert Wood Johnson University Hospital
No requirement for urgent surgery (i.e., surgery that cannot wait for 2 weeks)
PATIENT CHARACTERISTICS:
Not pregnant or nursing
Negative pregnancy test
Patients deemed in adequate health to undergo colon resection by their surgeon
No uncontrolled diabetes, uncontrolled BP, chronic congestive heart failure, or history of renal insufficiency
No personal or family history of bleeding disorders
No known history of problems absorbing fats (e.g., Crohn disease, cystic fibrosis)
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior chemotherapy or radiotherapy for the treatment of this cancer
More than 2 weeks since prior NSAIDs or corticosteroids
No concurrent colestipol or orlistat
No concurrent warfarin or dicumarol
No concurrent supplementation of vitamin E
A multivitamin containing ≤ 60 IU vitamin E allowed
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New Brunswick New Jersey, 08903, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.