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SAMe in Prevention of Oxaliplatin-associated Liver Injury

StatusNot Yet Recruiting
PhasePhase 2
Started2026-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Aug 2028 → Oct 2028
See other at-risk trials from Cedars-Sinai Medical Center

Amendment history

2026-10-01
Primary completion pushed: 2028-08 → 2028-10
Completion pushed: 2028-08 → 2028-10
2026-05-01
Study Status, Contacts/Locations v8
Primary completion pushed: 2028-06 → 2028-08
Completion pushed: 2028-06 → 2028-08
Start date2026-03→2026-07
Study sitescontacts updated at 2 of 2 sites
2026-03-16
Study Status v7
Primary completion date2028-04→2028-06
Completion date2028-04→2028-06
Start date2025-12→2026-03
2025-11-03
Study Status v6
Primary completion date2028-02-15→2028-04
Completion date2028-02-15→2028-04
Start date2025-09-15→2025-12
2025-09-02
Study Status v5
Primary completion date2027-12-15→2028-02-15
Completion date2027-12-15→2028-02-15
Start date2025-07-15→2025-09-15
Show 4 earlier versions
2025-06-03
Study Status v4
Primary completion date2027-11-15→2027-12-15
Completion date2027-11-15→2027-12-15
Start date2025-04-15→2025-07-15
2025-04-14
Study Status, Contacts/Locations v3
Primary completion date2026-10-15→2027-11-15
Completion date2026-10-15→2027-11-15
Start date2024-08-01→2025-04-15
Study sitescontacts updated at 2 of 2 sites
2024-06-03
Study Status v2
Start date2024-04-15→2024-08-01
2024-02-15
Study Status, Outcome Measures v1
Primary endpoints1 entry, revised
To identifyevaluate the effectefficacy of SAMe in preventing oxaliplatin associated liver injury a [...]
2024-02-06
Original filing
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.
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 2026-10
Primary Completion 2028-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-30