SAMe for Liver Injury in Colorectal Cancer

Recruiting at 1 trial location

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Olanzapine, MAO inhibitors

Disqualifiers: HIV, Cirrhosis, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, like olanzapine and MAO inhibitors, at least 14 days before starting the trial and during the study. If you're on vitamin E or anti-diabetic medications, you must be on a stable dose for a specific period before the trial. Check with the study team about any other medications you are taking.

Is SAMe safe for use in humans?

SAMe has been studied for its role in liver health and shows potential protective effects against liver injury, including from alcohol and chemotherapy. While it appears to be generally safe, more research is needed to fully understand its safety and effectiveness in humans. ^{1 2 3 4 5}

How does the drug SAMe differ from other treatments for liver injury in colorectal cancer?

SAMe (S-adenosylmethionine) is unique because it is a naturally occurring compound in the body that helps protect the liver by regulating cell growth and death, unlike traditional drugs that may not address these specific mechanisms. It is particularly noted for its role in maintaining liver health and preventing further liver damage, which is different from standard chemotherapy drugs that can often cause liver injury. ^{1 2 3 6 7}

What data supports the effectiveness of the drug SAMe for liver injury in colorectal cancer?

Research shows that SAMe has protective effects on the liver in animal models of liver injury and is effective in patients with certain liver diseases. It helps regulate liver cell growth and death, which may be beneficial in managing liver injury. ^{1 3 6 8 9}

Who Is on the Research Team?

Alexandra Gangi

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with colorectal cancer that has spread to the liver, where it can still be removed by surgery. Participants will receive standard chemotherapy and undergo surgery. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

I have taken a pregnancy test in the last 14 days and it was negative.

I am scheduled for liver surgery after chemotherapy with oxaliplatin.

Exclusion Criteria

Pregnant, breastfeeding, expecting to conceive or father children within the projected duration of the trial

Active infection as evidenced by positive urine culture, blood culture, or pneumonia

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAMe supplementation and oxaliplatin-based chemotherapy for 3-6 months

3-6 months

Surgery

Surgical removal of colorectal liver metastases

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 months

What Are the Treatments Tested in This Trial?

Interventions

• S-adenosylmethionine (SAMe)

Trial Overview The study tests if taking a supplement called S-adenosylmethionine (SAMe) can prevent liver damage from oxaliplatin-based chemotherapy in patients undergoing treatment for colorectal cancer that has spread to the liver.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Jarrow Formulas Inc

Industry Sponsor

Trials

6

Recruited

650+

Published Research Related to This Trial

S-adenosyl-L-methionine (SAMe) plays a crucial role in various cellular processes, including the synthesis of glutathione and methylation reactions, which are important for liver health.

Although pre-clinical studies suggest that SAMe may help protect the liver and improve disease severity, there is currently a lack of large, high-quality randomized clinical trials to confirm its effectiveness in treating liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

S-adenosylmethionine (SAMe) therapy in liver disease: a review of current evidence and clinical utility. Anstee, QM., Day, CP.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Role of S-adenosyl-L-methionine in liver health and injury. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

S-adenosylmethionine (SAMe) therapy in liver disease: a review of current evidence and clinical utility. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

S-adenosylmethionine in the chemoprevention and treatment of hepatocellular carcinoma in a rat model. [2021]

4. Greece pubmed.ncbi.nlm.nih.gov

Oral Recombinant Methioninase Overcomes Colorectal-cancer Liver Metastasis Resistance to the Combination of 5-Fluorouracil and Oxaliplatinum in a Patient-derived Orthotopic Xenograft Mouse Model. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of SAMe and betaine on Hepa 1-6, C34 and E47 liver cell survival in vitro. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The use of SAMe in chemotherapy-induced liver injury. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Role of S-adenosyl-L-methionine in the treatment of alcoholic liver disease: introduction and summary of the symposium. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Review article: S-adenosyl-L-methionine--a new therapeutic agent in liver disease? [2019]

9. England pubmed.ncbi.nlm.nih.gov

S-adenosylmethionine and proliferation: new pathways, new targets. [2021]