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Trial record 3 of 168 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00905918
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : September 30, 2014
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 21, 2009
Last Update Posted Date September 30, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
  • Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2 [ Time Frame: 4 years ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2009)
  • 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
Change History Complete list of historical versions of study NCT00905918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer
Official Title  ICMJE A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Colon
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Dietary Supplement: vitamin E
    Given orally
  • Other: laboratory biomarker analysis
    All patients undergo biomarker analyses
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: vitamin E
    • Other: laboratory biomarker analysis
  • Experimental: Arm III
    Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.
    Interventions:
    • Dietary Supplement: vitamin E
    • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2014)
14
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2009)
50
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00905918
Other Study ID Numbers  ICMJE 120901
CDR0000642446 ( Other Identifier: NIH )
0220090065 ( Other Identifier: IRB )
P30CA072720 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey
Investigators  ICMJE
Principal Investigator: Susan Goodin, PharmD, FCCP, BCOP Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP