Can a common supplement stop colon polyps? new trial aims to find out
NCT ID NCT07582003
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times
Summary
This early-stage trial tests whether a daily supplement called SAMe can help prevent colorectal polyps (precursors to colon cancer) in 18 adults who have already had surgery for early-stage colon cancer. Participants will take SAMe for up to a year while researchers monitor for side effects and check for new polyps during follow-up colonoscopy. The main goal is to find the safest and most effective dose for future larger studies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Other studies related to the condition(s) this trial covers.
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