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A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Colon


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Colon


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Susan Goodin, PharmD, FCCP, BCOP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Institutional Review Board

Study ID:

120901

NCT ID:

NCT00905918

Start Date:

June 2009

Completion Date:

June 2014

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903