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SAMe for Liver Injury in Colorectal Cancer

Phase 2

Waitlist Available

Led By Alexandra Gangi, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage IV patients with resectable liver predominant metastatic colorectal cancer referred to Cedars Sinai Medical Center for oxaliplatin based systemic therapy

Age ≥ 18 years

Must not have

Pre-existing grade ≥ 3 neuropathy precluding use of oxaliplatin

Known additional malignancy that is progressing or requires active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if taking S-adenosylmethionine (SAMe) supplements can help prevent liver damage caused by chemotherapy in patients with colorectal cancer that has spread to the liver

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of SAMe may include digestive discomfort, such as nausea and diarrhea, and less commonly, skin rashes or mood changes. Oxaliplatin can cause nerve damage, allergic reactions, and blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stage IV colorectal cancer with liver metastases and am referred for specific chemotherapy.

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I am 18 years old or older.

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I am scheduled for liver surgery after chemotherapy with oxaliplatin.

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I can take care of myself but might not be able to do active work.

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I am using or willing to use birth control, or I cannot have children, or I will not have heterosexual sex during the study and for 120 days after.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe nerve damage that prevents me from using oxaliplatin.

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I have another cancer that is getting worse or needs treatment.

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I am HIV positive.

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I haven't used any cancer treatments in the last 28 days.

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I had chemotherapy for cancer that spread within the last 6 months.

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I have had cirrhosis, hepatitis, liver transplant, or severe liver disease.

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I have a history of Parkinson's disease or bipolar disorder.

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I am not taking medications like Olanzapine or MAO inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

To Estimate the Objective Response Rate (ORR) of SAMe when taken with oxaliplatin based chemotherapy.

To evaluate changes in average estimated blood loss (EBL) in patients undergoing liver resection as compared to historical controls.

To evaluate length of hospital stay (LOS) in patients undergoing liver resection as compared to historical controls.

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