Study on Aspirin for Preventing Colorectal Cancer in Patients with Colorectal Adenoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02965703

Provider View

This clinical trial is exploring how well aspirin can prevent colorectal cancer in patients who have colorectal adenomas. The study aims to see if aspirin can stop tumor growth by blocking certain enzymes needed for cell growth.

Patient Parameters

Program Overview

This study is investigating whether taking aspirin can help prevent colorectal cancer in people who have colorectal adenomas, which are a type of polyp that can develop into cancer. Aspirin might work by stopping the growth of tumor cells by blocking certain enzymes that help cells grow.

Description

The main goal of this study is to compare two different schedules of taking aspirin to see if they are equally effective. Researchers will also look at how aspirin affects cell growth and death in the colon, as well as any side effects like blood in the stool.

Participants will be divided into three groups:

  • Group 1 will take aspirin every day for 12 weeks.
  • Group 2 will take aspirin for three weeks, then a placebo for three weeks, and repeat this cycle for 12 weeks.
  • Group 3 will take a placebo every day for 12 weeks.

Throughout the study, participants will provide blood, urine, stool, and tissue samples for analysis. After the study, participants will have a follow-up visit one month later.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with colorectal adenoma.
  • Age 18 years or older.
  • Good overall health with a performance status score of 0 or 1.
  • Adequate blood cell counts and organ function as determined by specific blood tests.
  • Negative test for blood in the stool.
  • Women and men of childbearing potential must agree to use effective contraception during the study.
  • Ability to understand and sign a consent form.

Exclusion Criteria

  • Recent or planned use of aspirin, NSAIDs, or certain other medications during the study.
  • History of certain cancers, kidney or liver diseases, or gastrointestinal conditions like ulcers or inflammatory bowel disease.
  • History of allergic reactions to aspirin.
  • Uncontrolled health conditions like heart failure or psychiatric illness.
  • Pregnant or breastfeeding women.

Locations

FACILITYZIPCITYSTATE
Vanderbilt University/Ingram Cancer Center37232NashvilleTennessee

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