SAMe in Prevention of Oxaliplatin-associated Liver Injury
A Phase II, Open-Label Trial of S-Adenosylmethionine (SAMe) in Prevention of Oxaliplatin Associated Liver Injury
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether SAMe supplements can prevent liver damage from oxaliplatin, a chemotherapy drug. It is for adults with colon or rectal cancer that has spread mainly to the liver and can be removed with surgery. Patients take SAMe for 3–6 months along with chemotherapy, then have surgery to remove the cancer in the liver.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have stage IV colon or rectal cancer that has spread mainly to the liver. The cancer may be newly found or have returned.
- Be referred to Cedars Sinai Medical Center for chemotherapy with oxaliplatin, with plans for liver surgery afterward.
- Be able to do at least some daily activities and self-care, based on the study’s activity scores.
- Have tests showing that organs and bone marrow, which makes blood cells, work well enough within 28 days before treatment.
- If able to become pregnant, have a negative pregnancy test within 14 days before treatment. Follow the study’s birth control or no-sex rules through 120 days after the last dose. Men must also use birth control during treatment and for 120 days afterward.
- If taking vitamin E at 800 IU a day or more, meet the study’s 180-day rules for a steady dose or stopping it. Diabetes medicine doses must be steady for at least 90 days before screening.
- Give written consent and be able to follow the study requirements.
Who can't join
- Use of an experimental drug or device within 4 weeks before treatment, or other cancer treatment from 28 days before enrollment through the final study visit.
- Past chemotherapy for cancer that has spread. Treatment before or after surgery is allowed if it ended at least 6 months before the cancer returned. Another cancer that is growing or needs treatment also excludes you.
- Severe nerve damage that prevents oxaliplatin use, an allergy to a study drug or supplement, or trouble swallowing or absorbing the supplement.
- Pregnancy, breastfeeding, or plans to become pregnant or father a child during the study or within 120 days after treatment.
- A history of liver scarring, hepatitis A, B, or C, fatty liver disease not caused by alcohol, liver transplant, or severe loss of liver function.
- HIV or an active infection; unstable heart disease, heart attack, heart bypass surgery, a procedure to open heart arteries, stroke, or mini-stroke within the past 6 months.
- A history of Parkinson’s disease or bipolar disorder, or another condition that the study doctor thinks could make participation unsafe or prevent completion.
- Taking olanzapine or an MAO inhibitor during the 14 days before treatment or during treatment. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine. Other antipsychotic medicines may also exclude you.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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: 1. No changes in prescribed dose within 180 days of the screening visit and 2. No new vitamin E-containing medications within 180 days of the screening visit or 3. Discontinuation of vitamin E ≥800 IU/day for at least 180 days prior to the screening visit. * 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 Criteria: * 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. Patients taking the following prohibited medications: * 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.
Study sites (2)
CA
- Cedars-Sinai Medical Center at SOCC · Los Angeles, CA 90048Clinical Trial Recruitment Navigator · Study contact · 310-423-5842 · GroupCancerTrialInformation@cshs.orgAlexandra Gangi, MD · Principal investigatorJun Gong, MD · Sub-investigatorAndrew Hendifar, MD · Sub-investigatorMore trials in Los Angeles
- Cedars-Sinai Medical Center Beverly Hills · Los Angeles, CA 90211Clinical Trial Recruitment Navigator · Study contact · 310-423-5842 · GroupCancerTrialInformation@cshs.orgAlexandra Gangi, MD · Principal investigatorJeremy Lorber, MD · Sub-investigatorKevin S. Scher, MD · Sub-investigatorMore trials in Los Angeles