S-Adenosylmethionine for Colorectal Cancer Prevention

Overseen By Clinical Trial Recruitment

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jun Gong, MD

Must not be taking: High-dose aspirin

Disqualifiers: Familial adenomatous polyposis, Hereditary nonpolyposis colorectal cancer, Inflammatory bowel disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the optimal dose of S-Adenosylmethionine (SAMe), a daily supplement, to prevent the recurrence of colorectal cancer by reducing the formation of colorectal polyps, which can develop into cancer. The study targets individuals who have had stage I or II colorectal cancer surgically removed and are not undergoing chemotherapy. Participants should be prepared to take SAMe for up to a year and consent to tests such as stool samples and colon biopsies before and after the treatment. The research will also assess whether SAMe influences gut health and other body markers. As a Phase 1 trial, this study focuses on understanding how SAMe functions in people, offering participants the chance to be among the first to receive this treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken high-dose aspirin in the past 60 days. Low-dose aspirin for heart health is allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that S-Adenosylmethionine (SAMe) might be safe for people. In earlier studies, SAMe showed promise in slowing the growth of colorectal cancer. These studies also suggest that SAMe is generally well-tolerated by patients. The current trial is in its early stage, focusing on assessing SAMe's safety and determining the right dose. Researchers aim to ensure it doesn't cause harmful side effects at the tested doses. So far, similar studies have reported no major safety issues, and the trial is conducted carefully to find a safe dosage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

S-Adenosylmethionine (SAMe) is unique because it offers a new approach to preventing colorectal cancer by potentially modifying epigenetic markers that influence cancer risk. Unlike standard treatments that typically focus on removal of polyps or chemotherapy to target existing cancer cells, SAMe is being investigated for its ability to prevent cancer from developing in the first place. Researchers are excited about this treatment because it leverages a natural compound, which is already present in the body, to potentially reduce cancer risk through a novel mechanism. This approach could lead to a less invasive and more preventive strategy for managing colorectal cancer.

What evidence suggests that S-Adenosylmethionine might be an effective treatment for colorectal cancer prevention?

Research suggests that S-Adenosylmethionine (SAMe), the substance tested in this trial, might help prevent colorectal cancer. Studies with animals and cells have shown that SAMe can slow the growth of certain tumors. Additionally, SAMe and a similar compound, methylthioadenosine (MTA), have reduced colon cancer caused by inflammation and blocked important cancer development pathways. These early findings indicate possible protective effects against colorectal cancer, but more research with humans is needed to confirm this. ^{2 3 4 6 7}

Who Is on the Research Team?

Jun Gong, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who have had surgery to remove stage I or II colorectal cancer, are not receiving chemotherapy, and can provide stool samples and colon biopsies before and after taking the study supplement. Participants must not be pregnant or breastfeeding.

Inclusion Criteria

I am 18 or older and had stage I-II colorectal cancer removed by surgery.

Must agree to pre-intervention (baseline) stool sample and distal colon biopsy

I am willing to provide stool and colon biopsy samples after my last study treatment.

Exclusion Criteria

I have a history of familial adenomatous polyposis (FAP).

I have a history of hereditary nonpolyposis colorectal cancer.

I have not taken high-dose aspirin in the past 60 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-finding

Participants receive varying doses of SAMe to determine the recommended phase II dose (RP2D)

4 weeks

Weekly visits for dose adjustment and monitoring

Treatment

Participants receive daily oral SAMe for chemoprevention of colorectal adenomas

12 months

Monthly visits for monitoring and assessment

Follow-up

Participants undergo postoperative surveillance colonoscopy and monitoring for safety and effectiveness

1 year

1 visit for colonoscopy

What Are the Treatments Tested in This Trial?

Interventions

• S-Adenosylmethionine (SAMe)

Trial Overview

The study tests daily oral S-Adenosylmethionine (SAMe) supplements to find the safest dose that may help prevent new colon polyps in people at risk of colorectal cancer after surgery. All participants receive SAMe for up to 12 months.

How Is the Trial Designed?

Group I: S-Adenosylmethionine (SAMe) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jun Gong, MD

Lead Sponsor

Trials

1

Recruited

20+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7464653/

S-Adenosylmethionine Treatment of Colorectal Cancer Cell ...

Nevertheless, based on the results of animal and cell culture experiments, SAM has been proven to have an inhibitory effect on certain tumors ...

2.

uclahealth.org

uclahealth.org/news/article/look-latest-progress-colorectal-cancer-prevention-and

A look at the latest progress in colorectal cancer prevention ...

The combination reduced the risk of death by about 20% and doubled the percentage of patients alive at two years. Researchers believe zanzalintinib helps ...

3.

academic.oup.com

academic.oup.com/carcin/article-pdf/33/2/427/17291171/bgr295.pdf

Effects of S-adenosylmethionine and methylthioadenosine on ...

In conclusion, SAMe and MTA reduced inflammation-induced colon cancer and inhibited several pathways important in colon carcinogenesis. Introduction. Colon ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07582003

A Phase I Trial of S-Adenosylmethionine (SAMe) for ...

We hypothesize that SAMe is safe and tolerable with preliminary efficacy in reducing rates of adenoma formation in subjects with stage I-II ...

5.

cdc.gov

cdc.gov/pcd/issues/2020/20_0039.htm

Preventing Breast, Cervical, and Colorectal Cancer Deaths

Increasing use of colorectal cancer screening would prevent more deaths than an equivalent increase in breast and cervical cancer screening.

6.

asco.org

asco.org/about-asco/press-center/news-releases/glp-1-receptor-agonists-may-help-reduce-risk-developing-colorectal-cancer

GLP-1 Receptor Agonists (GLP-1s) May Help Reduce ...

— People who took a glucagon-like peptide-1 receptor agonist (GLP-1) were 36% less likely to get colorectal cancer than people who took aspirin, ...

7.

withpower.com

withpower.com/trial/phase-1-colorectal-neoplasms-5-2026-bb886

S-Adenosylmethionine for Colorectal Cancer Prevention

The study investigates what the appropriate dosage of SAMe is so that there is the lowest risk of side effects, and whether the supplement will ...