NCT06258525

SAMe in Prevention of Oxaliplatin-associated Liver Injury

A Phase II, Open-Label Trial of S-Adenosylmethionine (SAMe) in Prevention of Oxaliplatin Associated Liver Injury

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Liver Metastases
• Liver Metastasis Colon Cancer
• Liver Injury
• Sinusoidal Obstruction Syndrome
• 5-Fluorouracil Toxicity
• Liver Toxicity, Chemically-Induced

Interventions

Type	Name	Description
RADIATION	Standard of care oxaliplatin-based chemotherapy	mFOLFOX6 or CAPOX
DIETARY_SUPPLEMENT	S-adenosylmethionine (SAMe) supplement	(400 mg tablet): 2 tablets taken orally AM and 1 tablet PM daily (total 1,200 mg daily) prior to surgical resection
PROCEDURE	Surgery	At 1-Month

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-02-14
• Last updated: 2026-03-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study