Status:
COMPLETED
Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 h...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00905918
Start Date
June 1 2009
End Date
May 1 2014
Last Update
September 30 2014
Active Locations (1)
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1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903