Clinical trial · Interventional
Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer
A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Prostate
- 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 supplements may stop or delay the development of prostate cancer in patients who are at risk of prostate cancer or who have prostate cancer. It is not yet known which vitamin E regimen is more effective in preventing prostate cancer. PURPOSE: This randomized phase I trial is comparing vitamin E supplement regimens to see how well they work in preventing cancer in patients at risk of prostate cancer or who have prostate 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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sham intervention | Procedure | — | UNRESOLVED |
| vitamin E | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- SHAM_COMPARATOR
- label
- Arm I
- description
- Patients receive no supplementation.
- interventionNames
- Procedure: sham intervention
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.
- interventionNames
- Dietary Supplement: vitamin E
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Meets one of the following criteria: * Abnormal digital rectal examination or abnormal prostate specific antigen (\> 4.0 ng/mL) * Obstructing prostate * Biopsy-proven prostate cancer * Scheduled to undergo prostate surgery (i.e., transurethral prostatectomy or prostatectomy) PATIENT CHARACTERISTICS: * No uncontrolled diabetes, uncontrolled blood pressure, chronic congestive heart failure, or history of renal insufficiency * No personal or family history of a bleeding disorder * No known history of problems absorbing dietary fats (e.g., Crohn's disease, cystic fibrosis) PRIOR CONCURRENT THERAPY: * More than 2 weeks since prior NSAIDs or corticosteroids * No concurrent supplementation of vitamin E (a multivitamin containing ≤ 60 IU of vitamin E is allowed) * No concurrent colestipol or orlistat * No concurrent warfarin or dicumarol
References
Publications (0)
Data not yet available