Clinical trial · Interventional
Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer
A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Colon
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| vitamin E | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Arm I
- description
- Patients receive no intervention before undergoing planned surgery.
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery.
- interventionNames
- Dietary Supplement: vitamin E
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available