SAMe in Prevention of Oxaliplatin-associated Liver Injury

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT06258525
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Single Arm

Primary Outcome Measure

To evaluate the efficacy of SAMe in preventing oxaliplatin associated liver injury as determined by lack of injury on histopathologic analysis in patients with liver only stage IV colorectal cancer. [ Time Frame: 8 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center at SOCCLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Alexandra Gangi, MD (PRINCIPAL_INVESTIGATOR)
Jun Gong, MD (SUB_INVESTIGATOR)
Andrew Hendifar, MD (SUB_INVESTIGATOR)
Arsen Osipov, MD (SUB_INVESTIGATOR)
Maha Guindi, MD (SUB_INVESTIGATOR)
Cedars-Sinai Medical Center Beverly HillsLos AngelesCalifornia90211
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Alexandra Gangi, MD (PRINCIPAL_INVESTIGATOR)
Jeremy Lorber, MD (SUB_INVESTIGATOR)
Kevin S. Scher, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Cedars-Sinai Medical Center at SOCC· Los Angeles, CACedars-Sinai Medical Center Beverly Hills· Los Angeles, CA

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