Actively Recruiting
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 2026-06-01
40
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the effects of naproxen and aspirin on the immune system in people with Lynch Syndrome, a condition that increases the risk of colorectal cancer. This Phase IIa clinical trial aims to understand how these drugs affect the number and types of immune cells, especially T cells, in the normal colon tissue. The study also evaluates impacts on gene expression, immune cell distribution, polyp burden, and the safety of these treatments in participants with Lynch Syndrome. Participants are randomly assigned to take either naproxen or aspirin capsules once daily, at about the same time each day, for an average of one year. The trial includes two treatment groups: one receiving naproxen and the other aspirin. Participants undergo two lower gastrointestinal endoscopies with biopsies, spaced 12 months apart, to assess changes in the colon tissue. The study also monitors the microbiome in normal mucosa, stool, and periodontal areas. During the trial, participants will have regular assessments including tissue biopsies, blood tests, and symptom evaluations. Researchers will measure the abundance of immune cells and gene activity in the colon and endometrium. The study tracks safety and side effects throughout. Participants must agree to follow study rules, including avoiding aspirin or similar drugs outside the study and undergoing yearly colonoscopies. The total involvement lasts about one year, with close monitoring by the research team.
CONDITIONS
Brief Title
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of Lynch syndrome by genetic mutation or history of mismatch repair deficient lesions or tumors
- No evidence of active or recurrent cancer for at least 6 months
- At least 6 months since any prior cancer treatment
- Have an intact distal colon and/or rectum accessible by endoscopy
- Consent to two lower GI endoscopies with biopsies spaced 12 months apart
- Agree to avoid aspirin, NSAIDs, or COX-inhibitors during the trial
- ECOG performance status of 0 or 1 or Karnofsky score of 70% or higher
- Normal organ and marrow function as defined by specified blood count and chemistry levels
- Women of childbearing potential must use effective contraception and agree to pregnancy testing
- Ability and willingness to provide informed consent and comply with study restrictions
- Willingness to undergo yearly screening colonoscopy during the trial
You will not qualify if you...
- Presence of two somatic mutations or loss of heterozygosity in mismatch repair genes in tumors
- Use of NSAIDs or COX-inhibitors for more than 3 days within 2 weeks before screening (except low-dose aspirin if willing to stop 7 days before study start)
- Complete removal of colon and rectum (total proctocolectomy)
- Active gastroduodenal ulcer disease in the past 5 years
- History of transfusion-dependent GI bleeding, perforation, or obstruction (unless due to removed malignancy)
- History of heart attack, stroke, or major heart surgery in the past 5 years
- Use of prohibited medications unless willing to stop at least 7 days before starting study drugs
- Uncontrolled kidney failure or insufficiency
- Allergic reactions to naproxen or aspirin
- Uncontrolled infections, high blood pressure, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Pregnant or breastfeeding women or women unwilling to use reliable contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants take either naproxen or aspirin daily by mouth to evaluate their effects on immune cells in the colorectal mucosa and other outcomes.
Two lower GI endoscopy visits with biopsies spaced 12 months apart
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eduardo Vilar-Sanchez, MD
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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