Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00905918
First received: May 20, 2009
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Dietary Supplement: vitamin E
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Colon

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm I
Patients receive no intervention before undergoing planned surgery.
Experimental: Arm II
Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery.
Dietary Supplement: vitamin E
Given orally
Other: laboratory biomarker analysis
All patients undergo biomarker analyses
Experimental: Arm III
Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.
Dietary Supplement: vitamin E
Given orally
Other: laboratory biomarker analysis
All patients undergo biomarker analyses

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905918

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Susan Goodin, PharmD, FCCP, BCOP Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00905918     History of Changes
Other Study ID Numbers: 120901, CDR0000642446, IRB#0220090065, P30CA072720
Study First Received: May 20, 2009
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 19, 2014