Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer

NCT ID: NCT00905918

Last Updated: 2014-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-05-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive no intervention before undergoing planned surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm II

Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery.

Group Type: EXPERIMENTAL

vitamin E

Intervention Type: DIETARY_SUPPLEMENT

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

All patients undergo biomarker analyses

Arm III

Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.

Group Type: EXPERIMENTAL

vitamin E

Intervention Type: DIETARY_SUPPLEMENT

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

All patients undergo biomarker analyses

Interventions

vitamin E

Given orally

Intervention Type: DIETARY_SUPPLEMENT

laboratory biomarker analysis

All patients undergo biomarker analyses

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Goodin, PharmD, FCCP, BCOP

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

CDR0000642446

Identifier Type: OTHER

Identifier Source: secondary_id

0220090065

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

120901

Identifier Type: -

Identifier Source: org_study_id