Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer
Information source: University of Medicine and Dentistry New Jersey
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: vitamin E (Dietary Supplement); laboratory biomarker analysis (Other)
Phase: Phase 1
Sponsored by: University of Medicine and Dentistry New Jersey
Official(s) and/or principal investigator(s):
Susan Goodin, PharmD, FCCP, BCOP, Principal Investigator, Affiliation: Cancer Institute of New Jersey
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
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.
Official title: A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Colon
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2
Plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine and urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG)
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
- 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
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- No requirement for urgent surgery (i. e., surgery that cannot wait for 2 weeks)
- 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
Locations and Contacts
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey, Phone: 732-235-8675
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2009
Last updated: June 12, 2012