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SAMe supplement may shield liver from chemo harm

NCT ID NCT06258525

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking S-adenosylmethionine (SAMe), a natural supplement, can prevent liver injury caused by the chemotherapy drug oxaliplatin. About 30 adults with colorectal cancer that has spread to the liver will take SAMe pills daily for 3-6 months alongside their chemo, then have liver surgery. Researchers will check liver tissue for damage and compare it to past patients who did not take SAMe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Stage IV patients with resectable liver predominant metastatic colorectal cancer (new diagnosis or recurrent) referred to Cedars Sinai Medical Center for oxaliplatin based systemic therapy. * Age ≥ 18 years. * Patients who are planning to undergo liver resection following oxaliplatin based chemotherapy treatment. * ECOG Performance Status 0-2 or Karnofsky Performance Status (KPS) ≥ 60%. * Demonstrate adequate organ and marrow function (within 28 days of study treatment initiation) * Female subjects of childbearing potential should have a negative urine or serum pregnancy within 14 days prior to receiving the first dose of study medication for eligibility verification purposes. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female subjects of childbearing potential should be willing to use adequate methods of birth control (hormonal or barrier method of birth control) or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year. * Male subjects should agree to use an adequate method of contraception starting with the first dose of therapy through 120 days after the last dose of therapy. * Subjects taking vitamin E ≥800 IU/day must be on a stable dose defined as: 1. No changes in prescribed dose within 180 days of the screening visit and 2. No new vitamin E-containing medications within 180 days of the screening visit or 3. Discontinuation of vitamin E ≥800 IU/day for at least 180 days prior to the screening visit. * Subjects taking anti-diabetic medications must be on a stable dose for at least 90 days prior to the date of the screening visit. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study Exclusion Criteria: * Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment. * No other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) or investigational agent may be used from 28 days prior to registration and until the end-of-study visit. * Has previously received chemotherapy for metastatic disease (neoadjuvant or adjuvant therapy is allowed as long as treatment was completed ≥6 months prior to recurrence). * Has pre-existing grade ≥ 3 neuropathy precluding use of oxaliplatin. * Has known additional malignancy that is progressing or requires active treatment. * Has a known hypersensitivity to any of the study supplement/drugs (SAMe, oxaliplatin, flourouacil, folinic acid and capecitabine). * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has any gastrointestinal disorder (e.g., bowel obstruction) or neurologic condition (e.g., oropharyngeal dysphagia) that may result in impairment of oral intake, inability to swallow the oral supplement, and/or impairment of absorption of study drug in the opinion of the treating investigator. * Has previous clinical diagnosis of cirrhosis, has had known history of Hep A/B/C or nonalcoholic fatty liver disease (NAFLD), liver transplantation, or any other cause for decompensated liver disease. * Known human immunodeficiency virus (HIV) infection. * Any of the following within 6 months prior to the screening visit: unstable cardiovascular disease, myocardial infarction, coronary artery bypass surgery, coronary angioplasty, transient ischemic attack, or cerebrovascular accident. * Any other condition that, in the investigator's opinion, would impede competence or compliance or delay completion of the study. * History of Parkinson's disease or bipolar disorder. Patients taking the following prohibited medications: * Olanzapine * MAO inhibiters, including: * Isocarboxazid * Linezolid * Methylene blue injection * Phenelzine * Rasagiline * Selegiline * Tranylcypromine * Any other MAO inhibitors The above prohibited medications cannot be taken -14 days prior to Day 0 and during study treatment.. Patients currently on or plan to be prescribed anti-psychotic medications not listed above may be excluded at the discretion of the Investigator. - Active infection as evidenced by positive urine culture, blood culture, or pneumonia.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars-Sinai Medical Center Beverly Hills

    Los Angeles, California, 90211, United States

  • Cedars-Sinai Medical Center at SOCC

    Los Angeles, California, 90048, United States

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