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SAMe to Prevent Liver Injury from Oxaliplatin Chemotherapy

This study is looking at whether a supplement called S-adenosylmethionine (SAMe) can prevent liver injury in patients with colorectal cancer that has spread to the liver (liver metastases). These patients are receiving oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX) before surgery to remove the liver tumors. You would take two SAMe tablets in the morning and one in the evening daily for 3-6 months (about 6-8 cycles of chemotherapy), in addition to your standard chemotherapy. The main goal is to see if SAMe helps prevent liver injury, which will be checked by looking at your liver tissue after surgery. This study is for adults aged 18 or older with resectable (meaning it can be removed by surgery) liver-predominant metastatic colorectal cancer.

Study design
This is an open-label, phase II study, meaning both you and your doctors will know you are receiving SAMe. It plans to enroll 30 participants.
What's involved
You would take SAMe tablets daily for 3-6 months (about 6-8 cycles of chemotherapy) in addition to your oxaliplatin-based chemotherapy, followed by surgical removal of the liver metastases.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study will be measured at 8 months after starting the intervention.

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NCT06258525

SAMe in Prevention of Oxaliplatin-associated Liver Injury

Not Yet Recruiting
PHASE2Ages 18+InterventionalSupportive care
Cedars-Sinai Medical Center
~30 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Standard of care oxaliplatin-based chemotherapyS-adenosylmethionine (SAMe) supplementSurgery

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 8 months

Conditions

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

Explore related trials

Colorectal Carcinoma

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Alexandra Gangi, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Navigator
[email protected]
3104232133
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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.
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.

What this trial measures

  • 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.8 months

    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/obliteration, focal hepatocyte plate disruption, parenchymal extinction lesions, nodular regenerative hyperplasia, peliosis, and veno-occlusive like changes. Rate of sinusoidal obstruction syndrome (SOS), as measured by CVI Score, ranging from 0-13. A CVI score of 3 or more indicates SOS. Compared to historical controls.