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S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas

ConditionsColorectal Cancer (Diagnosis)Adenoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJun Gong, MD

About this trial

This study will enroll a total of 18 patients who have undergone curative surgery for stage I or II colorectal cancer and are planned for post-surgical surveillance without any need for chemotherapy at Cedars-Sinai Medical Center. All subjects will receive an oral daily supplement called S-Adenosylmethionine (SAMe) which has been hypothesized to reduce colorectal polyps (precursors to colorectal cancer) and prevent colorectal cancer formation. 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 prevent polyp formation in a population of patients who at risk for developing polyps and colorectal cancer. The primary endpoint will be to determine the recommended phase II dose (RP2D), the highest safe dose of SAMe that could be studied in larger clinical trials to advance this agent further in clinical development. Secondary endpoints include safety, the rate of postoperative adenomas detected on surveillance colonoscopy, and the effects of SAMe on the colon, specifically, its impact on gut bacteria and tissue markers before and after SAMe treatment to better understand the mechanisms to how SAMe may have its colorectal cancer preventive effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • S-Adenosylmethionine (SAMe)

    Drug

    S-Adenosylmethionine (SAMe) will be given at an oral daily dose of 1600-2400 mg daily divided into 400 mg tablets in the morning before breakfast and in the evening before dinner to constitute the total daily dose.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: S-Adenosylmethionine (SAMe)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recommended Phase II Dose (RP2D)

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.

Time frame
4 weeks post study treatment

Secondary outcomes

1

Rate of Adenomas

Rate of adenomas detected on postoperative surveillance colonoscopy performed within 1 year of surgery. Frequency of adenomas detected on postoperative surveillance colonoscopy following up to 12 months of SAMe treatment.

Time frame
Post treatment, roughly 1 year
2

Safety by Adverse Events

Safety will be categorized by adverse events according to type and severity based on NCI CTCAE Version 5.0

Time frame
Post treatment, roughly 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jun Gong, MD

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: