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SAMe in Prevention of Oxaliplatin-associated Liver Injury

NCT06258525 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jarrow Formulas Inc

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Alexandra Gangi, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06258525 on ClinicalTrials.gov