Clinical trial · Interventional
Resveratrol in Treating Patients With Colorectal Cancer That Can Be Removed By Surgery
Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients: Tolerability, Target Tissue Levels and Pharmacodynamics
NCT00433576CI-TRIAL-00015619completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This phase I trial is studying the side effects and best dose of resveratrol in treating patients with colorectal cancer that can be removed by surgery. Resveratrol may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
| Stage I Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| resveratrol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (resveratrol, colorectomy)
- description
- STAGE I: Patients undergo an colorectal endoscopy. Patients whose biopsies confirm colorectal adenocarcinoma histology and require surgical resection continue on study stage 2. STAGE II: Patients receive oral resveratrol on days 1-8. Patients undergo colorectomy on day 9. A tumor biopsy is performed during endoscopy and colorectomy for research purposes.
- interventionNames
- Drug: resveratrol
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Pharmacodynamics of resveratrol
- timeFrame
- Up to 8 days
- measure
- Concentrations of biomarkers
- timeFrame
- Up to day 9
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Stage 1:
* Radiological or clinical evidence of a colorectal malignancy
* Requires colorectal endoscopy for diagnosis
* Stage 2:
* Histologically confirmed adenocarcinoma of the colon or rectum by colorectal endoscopy in stage 1 study
* Resectable disease
* Planning to undergo colorectomy
* WHO performance status 0-2
* ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 1.5 mg/dL
* Hemoglobin ≥ 10 g/dL (transfusion allowed for anemia due to bleeding from the tumor)
* Suitable for general anesthesia
* No active peptic ulcer disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No excessive alcohol intake (more than UK recommended limit: 28 or 21 units per week for men or women, respectively)
* No other cancer that is currently under treatment, clinically detectable, or has been treated within the past 5 years (other than basal cell or squamous cell carcinomas)
* At least 6 months since prior and no concurrent participation in other invasive or drug studies
* No radiotherapy or chemotherapy within 4 weeks of endoscopic tissue sampling
* At least 24 hours since prior and no concurrent nonessential medications or nonsteroidal anti-inflammatory drugs
* No concurrent resveratrol-containing food and drink (e.g., wine, grapes, peanuts, mulberries, cranberries, blueberries, huckleberries)
* No concurrent vitamin supplements
* No concurrent chronic medications, including over-the-counter medications, that may interfere with the pharmacokinetics or pharmacodynamics measured
* No concurrent medication that could interfere with biomarker assay
* No concurrent anticoagulants including, warfarin and low molecular weight heparin
* No concurrent steroidsReferences
Publications (0)
Data not yet available
No reference posted for this study.