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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 is a Phase 2 study that has not yet begun recruiting, run by Cedars-Sinai Medical Center. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06258525
The ClinicalTrials.gov registry entry for NCT06258525 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Surgery is the first listed.
NCT06258525 reports 0 study locations.
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.
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