Study on SAMe Supplementation to Prevent Liver Injury from Oxaliplatin in Colorectal Cancer Patients

Sponsor: Cedars-Sinai Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06258525

Provider View

This clinical trial is exploring whether taking S-adenosylmethionine (SAMe) supplements can help prevent liver damage caused by the chemotherapy drug oxaliplatin in patients with colorectal cancer that has spread to the liver and can be surgically removed.

Patient Parameters

Program Overview

The study aims to find out if taking SAMe supplements can protect the liver from damage caused by oxaliplatin, a chemotherapy drug used in treating colorectal cancer that has spread to the liver. Patients will take SAMe tablets twice in the morning and once in the evening for 3 to 6 months, alongside their chemotherapy treatment, before undergoing surgery to remove the cancer from the liver.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with colorectal cancer that has spread to the liver and can be surgically removed.
  • Patients planning to have liver surgery after receiving oxaliplatin-based chemotherapy.
  • Good overall health with a performance status score of 0-2.
  • Adequate organ and bone marrow function based on recent tests.
  • Women of childbearing age must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 120 days after the last dose.
  • Men must agree to use effective contraception during the study and for 120 days after the last dose.
  • Patients taking high doses of vitamin E must have been on a stable dose for at least 180 days before the study.
  • Patients on anti-diabetic medications must have been on a stable dose for at least 90 days before the study.
  • Willingness to provide written informed consent and comply with study requirements.

Exclusion Criteria

  • Participation in another clinical trial or use of an investigational drug within 4 weeks before starting the study.
  • Use of other cancer treatments within 28 days before starting the study.
  • Previous chemotherapy for metastatic disease, unless completed more than 6 months before recurrence.
  • Severe nerve damage that prevents the use of oxaliplatin.
  • Other active cancers requiring treatment.
  • Allergies to any study drugs or supplements.
  • Conditions or treatments that could interfere with the study results or participation.
  • Pregnant or breastfeeding women, or those planning to conceive during the study.
  • Digestive or neurological conditions affecting the ability to take or absorb the study drug.
  • History of liver disease, including cirrhosis or hepatitis.
  • HIV infection.
  • Recent serious heart or blood vessel problems.
  • Conditions affecting the ability to participate or complete the study.
  • History of Parkinson's disease or bipolar disorder.
  • Use of certain medications, including specific antidepressants and antipsychotics, within 14 days before starting the study.
  • Active infections, such as urinary or blood infections, or pneumonia.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.