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NCT06258525 · ClinicalTrials.gov registry record · Phase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT06258525: Clinical Trial Phase 2 study, sponsored by Cedars-Sinai Medical Center.
NCT06258525 is a Phase 2 study that has not yet begun recruiting, run by Cedars-Sinai Medical Center. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06258525, a Phase 2 study, has not yet begun recruiting, sponsored by Cedars-Sinai Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
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.
Primary Outcome
To identify the effect 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. Improvement in liver injury will be measured by the degree/histopathologic grade of liver injury utilizing the Combined Vascular Injury (CVI) Score in non-cancerous liver tissue post therapy compared to historical controls. CVI score will evaluate and grade sinusoidal dilation, small vessel loss/oblite
Interventions
- PROCEDURE Surgery
- RADIATION Standard of care oxaliplatin-based chemotherapy
- DIETARY_SUPPLEMENT S-adenosylmethionine (SAMe) supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-07 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What is known before NCT06258525 opens enrollment
NCT06258525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Surgery is the first listed.
NCT06258525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06258525 about?
NCT06258525 is a clinical study titled "SAMe in Prevention of Oxaliplatin-associated Liver Injury". 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 wi...
What is the current status of trial NCT06258525?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-07. Estimated completion is 2028-08.
What interventions are being tested in trial NCT06258525?
The interventions under investigation include: Surgery (PROCEDURE), Standard of care oxaliplatin-based chemotherapy (RADIATION), S-adenosylmethionine (SAMe) supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06258525?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06258525's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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