Phase IIa Study of Naproxen or Aspirin for Cancer Prevention in Lynch Syndrome

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05411718

Provider View

This clinical trial is exploring how naproxen and aspirin affect the colon in people with Lynch Syndrome, a genetic condition that increases cancer risk. The study aims to understand the impact of these medications on immune cells and overall colon health.

Patient Parameters

Program Overview

The study aims to understand how naproxen and aspirin affect the immune cells in the colon of people with Lynch Syndrome, a genetic condition that increases the risk of certain cancers. Researchers will look at how these drugs influence immune cell types, gene expression, and the distribution of immune cells in the colon and endometrium. They will also assess the safety of these medications and their impact on colon polyps and the microbiome in the gut and mouth.

Description

This study is investigating the effects of naproxen and aspirin on the immune system in people with Lynch Syndrome, a condition that increases cancer risk. The main goal is to see how these drugs affect immune cells in the colon. Researchers will also look at how the drugs influence gene activity and the location of immune cells in the colon and endometrium. They will assess the safety of the drugs and their impact on colon polyps and the microbiome in the gut and mouth. Participants will be randomly assigned to receive either naproxen or aspirin and will undergo regular colonoscopies and other tests to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have Lynch Syndrome, either with a known genetic mutation or a history of specific types of tumors.
  • No active or returning cancer for at least 6 months.
  • At least 6 months since any cancer treatment like surgery, chemotherapy, or radiation.
  • Must have part of the colon or rectum intact for endoscopy.
  • Agree to undergo two colonoscopies with biopsies, 12 months apart.
  • Must not use aspirin or similar drugs during the trial.
  • Age 18 or older.
  • Good overall health with normal blood and organ function.
  • Women of childbearing potential must use effective birth control and agree to pregnancy tests.
  • Must understand and agree to the study requirements and sign a consent form.
  • Willing to have yearly colonoscopies during the trial.

Exclusion Criteria

  • Have two specific genetic changes in tumors.
  • Used certain pain relievers or blood thinners recently.
  • Had surgery to remove the entire colon and rectum.
  • Have active stomach ulcers or a history of severe gastrointestinal issues.
  • Have had a heart attack, stroke, or major heart surgery in the last 5 years.
  • Taking certain medications that cannot be stopped before the study.
  • Have severe kidney problems.
  • Allergic to naproxen or aspirin.
  • Have uncontrolled health issues like infections or heart problems.
  • Pregnant or breastfeeding women, or those not willing to use birth control.
  • Participants will include adults of all races and ethnicities, but not children.

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