Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05411718

A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome

Led by M.D. Anderson Cancer Center · Updated on 2025-11-13

40

Participants Needed

1

Research Sites

192 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.

CONDITIONS

Official Title

A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of Lynch syndrome by genetic mutation or history of specific MMR-deficient lesions or tumors
  • No active or recurrent cancer for at least 6 months
  • At least 6 months since any prior cancer treatment
  • Have accessible distal colon or rectal mucosa for biopsies
  • Agree to undergo two lower GI endoscopies 12 months apart with biopsies
  • Willing to avoid aspirin, NSAIDs, or COX-inhibitors during the trial
  • ECOG performance status 0 or 1, or Karnofsky score 70% or higher
  • Normal organ and marrow function as defined by blood counts and organ tests
  • Women of childbearing potential must use reliable contraception and have pregnancy tests
  • Ability to understand and sign informed consent
  • Willing to follow all study restrictions and undergo yearly screening colonoscopies
Not Eligible

You will not qualify if you...

  • Presence of two somatic mutations or loss of heterozygosity in MMR genes in tumors
  • Use of NSAIDs or COX-inhibitors for more than 3 days within 2 weeks before screening, except low-dose aspirin willing to stop 7 days prior
  • History of total removal of colon and rectum
  • Active gastroduodenal ulcer disease in past 5 years
  • History of transfusion-dependent GI bleeding, GI perforation, or obstruction unless due to removed malignancy
  • History of myocardial infarction, stroke, coronary artery bypass, or revascularization in past 5 years
  • Use of prohibited medications including certain NSAIDs, anticoagulants, anticonvulsants, antibiotics, and others unless willing to stop 7 days prior
  • Uncontrolled kidney failure
  • Allergy to naproxen or aspirin
  • Uncontrolled illness that would limit study compliance
  • Pregnant, breastfeeding, or unwilling to use contraception if a woman of childbearing potential

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

E

Eduardo Vilar-Sanchez, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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