Clinical Trial

SAMe in Prevention of Oxaliplatin-associated Liver Injury

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable colorectal liver metastases. Resectable means that it is able to removed with surgery. Patients will take two SAMe tablets in the morning and one tablet in the evening for 3-6 months (about 6-8 cycles of chemotherapy) in addition to oxaliplatin based chemotherapy followed by surgical removal of the colorectal liver metastases.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2028-06 -> 2028-08 2026-05-07
minor Completion pushed: 2028-06 -> 2028-08 2026-05-07
Trial Details
NCT Number NCT06258525
Lead Sponsor Cedars-Sinai Medical Center
Collaborators: Jarrow Formulas Inc
Conditions Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer, Liver Injury, Sinusoidal Obstruction Syndrome, 5-Fluorouracil Toxicity, Liver Toxicity, Chemically-Induced
Enrollment 30 participants
Start Date 2026-07
Primary Completion 2028-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-06