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Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
vitamin E
laboratory biomarker analysis
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm Description

Patients receive no intervention before undergoing planned surgery.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2009
Last Updated
September 26, 2014
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00905918
Brief Title
Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer
Official Title
A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Colon
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
No Intervention
Arm Description
Patients receive no intervention before undergoing planned surgery.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery.
Arm Title
Arm III
Arm Type
Experimental
Arm Description
Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin E
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
All patients undergo biomarker analyses
Primary Outcome Measure Information:
Title
Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2
Time Frame
4 years
Title
Plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine and urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG)
Time Frame
4 years
Title
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
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Goodin, PharmD, FCCP, BCOP
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer

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