Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905918
• Other study ID #: 120901
• Secondary ID: CDR0000642446022
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2009
• Last updated: September 26, 2014
• Start date: June 2009
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• vitamin E
Given orally

Other:
• laboratory biomarker analysis
All patients undergo biomarker analyses

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma and urine levels of a-, ?-, and d-tocopherols, and prostaglandin E2		4 years	No
Primary	Plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine and urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG)		4 years	No
Primary	Presence in colon tissue of a-, ?-, and d-tocopherols, cell proliferation and apoptosis indicators, ß-catenin localization, RXR expression, and cyclooxygenase-2, 8-OHdG, and 3-nitrotyrosine levels		4 years	No