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S-Adenosylmethionine (SAMe) for Preventing Colorectal Adenomas

This study is testing S-Adenosylmethionine (SAMe), an oral supplement, to see if it can help prevent colorectal polyps (growths that can become cancer) in people who have already had surgery for stage I or II colorectal cancer. The goal is to find the safest and most effective daily dose of SAMe. You would take SAMe daily for up to 12 months. To join, you must be an adult (18 or older) who has had surgery for stage I or II colorectal cancer and does not need chemotherapy. You'll also need to provide a stool sample and have a colon biopsy before starting the supplement. This study aims to find the best dose and see if SAMe can prevent polyps.

Study design
This is a single-institution study involving 18 participants. It is designed to evaluate the safety of S-Adenosylmethionine (SAMe).
What's involved
You would provide a stool sample and have a colon biopsy before starting the study. You would then take S-Adenosylmethionine (SAMe) daily for up to 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Recommended Phase II Dose (RP2D), is measured at 4 weeks post study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07582003

S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas

Not Yet Recruiting
PHASE1Ages 18+InterventionalPrevention
Jun Gong, MD
~18 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:S-Adenosylmethionine (SAMe)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase II Dose (RP2D)
Measured over 4 weeks post study treatment

Conditions

Colorectal Cancer (Diagnosis)
Adenoma

Explore related trials

AdenomaColorectal Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jun Gong, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Recruitment
[email protected]
310-423-5842
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults ≥18 years old with histologically confirmed, curatively resected stage I-II colorectal cancer
must agree to pre-intervention (baseline) stool sample and distal colon biopsy
must start study intervention within 30 days ±7 days of the baseline biopsy
must be able to complete up to 12 months of intervention prior to planned postoperative surveillance colonoscopy within 1 year of surgery
must undergo repeat stool sample and distal colon biopsy within 7 days ±4 days of the last dose of study intervention
did not receive adjuvant therapy
not currently breastfeeding or pregnant.

Exclusion

Have a history familial adenomatous polyposis (FAP)
have a history of hereditary nonpolyposis colorectal cancer
history of inflammatory bowel disease
high-dose aspirin (except for low-dose (≤100 mg/day) aspirin for cardiovascular prevention) within the past 60 days of enrollment.

What this trial measures

  • Recommended Phase II Dose (RP2D)4 weeks post study treatment

    The RP2D will be defined as the dose level closest to the median of the marginal posterior distribution of the of the maximum tolerated dose (MTD). The MTD is defined as the dose level such that the probability of a dose-limiting toxicity at the MTD is θ=0.33.