SAMe for Liver Injury in Colorectal Cancer

Not yet recruiting at 1 trial location

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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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether the supplement S-adenosylmethionine (SAMe) can prevent liver damage caused by the chemotherapy drug oxaliplatin. It targets individuals with colorectal cancer that has spread to the liver but remains operable. Participants will take SAMe tablets alongside their usual chemotherapy for 3-6 months. Suitable candidates have liver metastases from colorectal cancer and plan to undergo chemotherapy followed by surgery. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that S-adenosylmethionine (SAMe) is likely to be safe for humans?

Research shows that SAMe is generally safe, with very few side effects. In studies, most participants experienced only mild stomach issues that resolved quickly. SAMe has improved liver health, which is promising for those with liver concerns. It is already known to help treat liver problems, enhancing its safety record. This suggests that SAMe is likely well-tolerated, making it a potentially safe option for participants in this study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

S-adenosylmethionine (SAMe) is unique because it offers a potential new approach to managing liver injury in colorectal cancer patients. Unlike standard care options, which often focus on managing symptoms or slowing disease progression, SAMe targets the liver directly by acting as a methyl donor to support liver function and repair. Researchers are excited about SAMe because it not only has antioxidant properties but may also improve detoxification processes in the liver, potentially reducing chemotherapy-induced liver damage. This could make it a valuable complementary treatment in cancer care, enhancing patient outcomes and quality of life.

What evidence suggests that SAMe might be an effective treatment for liver injury in colorectal cancer?

Research has shown that S-adenosylmethionine (SAMe), the treatment under study in this trial, can improve liver health with few side effects, mainly mild stomach issues. Studies suggest that SAMe might protect the liver from damage caused by oxaliplatin, a chemotherapy drug for colorectal cancer. Early research also indicates that SAMe may help control the growth of colon cancer. While its role in liver health remains under investigation, these findings suggest SAMe could be a useful supplement for managing liver issues during cancer treatment. ^{1 4 5 6 7}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11547595/

S-Adenosylmethionine (SAMe) for Liver Health SAMe was effective in improving liver-related parameters with few adverse events, which were primarily mild, transient gastrointestinal complaints.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0168827812004096

S-adenosylmethionine (SAMe) therapy in liver disease Despite encouraging pre-clinical data confirming that SAMe depletion can exacerbate liver injury ... The results led the authors to conclude that 'SAMe was no ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06258525

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 ...

4. journals.physiology.org journals.physiology.org/doi/full/10.1152/physrev.00047.2011

S-adenosylmethionine in Liver Health, Injury, and Cancer AdoMet is effective in cholestasis of pregnancy, and its role in other human liver diseases remains to be better defined. In experimental models, it is ...

5. dtic.minsky.ai dtic.minsky.ai/W81XWH2110375/text

The Role of S-Adenosylmethionine in Protection Against ... Previous research has shown that it may have an effect in controlling the growth of metastatic colon cancer. Our preliminary research shows that ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842818301793

The use of SAMe in chemotherapy-induced liver injury S-adenosylmethionine (SAMe) is an endogenous agent derived from methionine. Its supplementation is effective in the treatment of liver disease, in particular ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3698976/

S-ADENOSYLMETHIONINE IN LIVER HEALTH, INJURY ... This review is focused mainly on the role of AdoMet in liver health, injury, and cancer. Much of current understanding has been gained through the use of ...