NCT07582003Not yet recruitingPhase 1
S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas
A Phase I Trial of S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 6 May 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- Jun Gong, MD
- Diseases
- Colorectal cancer
- NCT number
- NCT07582003
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 1 Nov 2026 to the primary completion date, 1 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- have a history of hereditary nonpolyposis colorectal cancer
- history of inflammatory bowel disease
Other
- Have a history familial adenomatous polyposis (FAP)
- high-dose aspirin (except for low-dose (≤100 mg/day) aspirin for cardiovascular prevention) within the past 60 days of enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.