S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas

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.

NCT Number	NCT07582003
Lead Sponsor	Jun Gong, MD
Conditions	Colorectal Cancer (Diagnosis), Adenoma
Enrollment	18 participants
Start Date	2026-11-01
Primary Completion	2028-11-01 (estimated)
Study Completion	2028-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-04