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Not yet recruitingPhase 1

S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas

A Phase I Trial of S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas

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
Not stated

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

  • Time periods mentioned: 12 months
  • Procedures mentioned: Biopsies, 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
  • "A goal n=18 participants will be enrolled to receive up to 12 months of oral SAMe as chemoprevention."
  • "A pre-intervention (baseline) stool sample and colon biopsy by a low-risk procedure called flexible sigmoidoscopy will be obtained."
  • "The study intervention (SAMe) will start within 30 days ±7 days of the baseline biopsy."
  • "Upon completion of up to 12 months of intervention, a postoperative surveillance colonoscopy (routinely performed within 1 year of curative surgery for stage I-II colorectal cancer) with repeat colon biopsy and a repeat stool sample within 7 days ±4 days of the last dose of study intervention will be obtained."
  • "The pre- and post-SAMe colon biopsies will be performed in the region of the colon known as the distal colon and tissue biopsies will undergo testing to evaluate the effects of SAMe on various proteins that are involved in the process by which adenomas and cancer arise from the normal colon."
  • "Patients will be actively participating in the study and consuming oral daily SAMe for a duration of up to 12 months."
Compensation
Not stated
  • 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 a daily SAMe supplement to find the highest safe dose and see if it may prevent colon or rectal polyps, growths that can turn into cancer. It is for adults who had surgery to remove stage I or II colon or rectal cancer and do not need chemotherapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, with stage I or II colon or rectal cancer confirmed by a tissue test and removed by surgery meant to cure it.
  • Agree to give a stool sample and a small tissue sample from the lower colon before treatment.
  • Start the study supplement within 30 days, plus or minus 7 days, of the first tissue sample.
  • Be able to take the supplement for up to 12 months before a planned colonoscopy, a test that looks inside the colon, within 1 year of surgery.
  • Give repeat stool and lower-colon tissue samples within 7 days, plus or minus 4 days, of the last dose.
  • Have not received added cancer treatment after surgery.
  • Not pregnant or breastfeeding.

Who can't join

  • Have a history of familial adenomatous polyposis (FAP), an inherited condition that causes many colon polyps.
  • Have a history of hereditary nonpolyposis colorectal cancer, an inherited condition that raises colon and rectal cancer risk.
  • Have a history of inflammatory bowel disease, which causes long-term swelling in the digestive tract.
  • Used high-dose aspirin in the 60 days before joining. Low-dose aspirin of 100 mg a day or less to prevent heart or blood vessel problems is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

CA