Clinical trial · Interventional
S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas
A Phase I Trial of S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas
- 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 study will enroll a total of 18 patients who have undergone curative surgery for stage I or II colorectal cancer and are planned for post-surgical surveillance without any need for chemotherapy at Cedars-Sinai Medical Center. All subjects will receive an oral daily supplement called S-Adenosylmethionine (SAMe) which has been hypothesized to reduce colorectal polyps (precursors to colorectal cancer) and prevent colorectal cancer formation. The study investigates what the appropriate dosage of SAMe is so that there is the lowest risk of side effects, and whether the supplement will prevent polyp formation in a population of patients who at risk for developing polyps and colorectal cancer. The primary endpoint will be to determine the recommended phase II dose (RP2D), the highest safe dose of SAMe that could be studied in larger clinical trials to advance this agent further in clinical development. Secondary endpoints include safety, the rate of postoperative adenomas detected on surveillance colonoscopy, and the effects of SAMe on the colon, specifically, its impact on gut bacteria and tissue markers before and after SAMe treatment to better understand the mechanisms to how SAMe may have its colorectal cancer preventive effects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer (Diagnosis) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-Adenosylmethionine (SAMe) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-Adenosylmethionine (SAMe)
- interventionNames
- Drug: S-Adenosylmethionine (SAMe)
Primary outcomes (1)
- measure
- Recommended Phase II Dose (RP2D)
- timeFrame
- 4 weeks post study treatment
- description
- The RP2D will be defined as the dose level closest to the median of the marginal posterior distribution of the of the maximum tolerated dose (MTD). The MTD is defined as the dose level such that the probability of a dose-limiting toxicity at the MTD is θ=0.33.
Secondary outcomes (2)
- measure
- Rate of Adenomas
- timeFrame
- Post treatment, roughly 1 year
- description
- Rate of adenomas detected on postoperative surveillance colonoscopy performed within 1 year of surgery. Frequency of adenomas detected on postoperative surveillance colonoscopy following up to 12 months of SAMe treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults ≥18 years old with histologically confirmed, curatively resected stage I-II colorectal cancer * must agree to pre-intervention (baseline) stool sample and distal colon biopsy * must start study intervention within 30 days ±7 days of the baseline biopsy * must be able to complete up to 12 months of intervention prior to planned postoperative surveillance colonoscopy within 1 year of surgery * must undergo repeat stool sample and distal colon biopsy within 7 days ±4 days of the last dose of study intervention * did not receive adjuvant therapy * not currently breastfeeding or pregnant. Exclusion Criteria: * Have a history familial adenomatous polyposis (FAP) * have a history of hereditary nonpolyposis colorectal cancer * history of inflammatory bowel disease * high-dose aspirin (except for low-dose (≤100 mg/day) aspirin for cardiovascular prevention) within the past 60 days of enrollment.
References
Publications (0)
Data not yet available