Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer

NCT00905918 | Completed Phase 1

• 4 other identifiers: 120901CDR00006424460220090065P30CA072720
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

colon cancer; rectal cancer

Outcome Measures

Primary Outcomes (3)

• Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2

  4 years

• Plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine and urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG)

  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

  4 years

Study Arms (3)

Arm I

NO INTERVENTION

Patients receive no intervention before undergoing planned surgery.

Arm II

EXPERIMENTAL

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

Dietary Supplement: vitamin E; Other: laboratory biomarker analysis

Arm III

EXPERIMENTAL

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

Dietary Supplement: vitamin E; Other: laboratory biomarker analysis

Interventions

vitamin E DIETARY_SUPPLEMENT

Given orally

Arm II; Arm III

laboratory biomarker analysis OTHER

All patients undergo biomarker analyses

Arm II; Arm III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Susan Goodin, PharmD, FCCP, BCOP

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: May 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

US (1)