NCT05411718

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary Objectives: * To evaluate the effect of naproxen or aspirin on the abundance of T cells and other im-mune cell types in the normal colorectal mucosa of participants with Lynch syndrome (LS) using single-cell approaches. Secondary Objectives: * To evaluate cell-type specific effects of treatment with naproxen or aspirin on gene ex-pression in the normal colorectal mucosa and endometrium in participants with LS using single-cell approaches. * To evaluate the effect of treatment with naproxen or aspirin on the spatial distribution of immune-related cell types in the normal colorectal mucosa and endometrium in of partic-ipants with LS using multiplex imaging approaches. * To assess the effect of treatment with naproxen or aspirin on colorectal polyp burden in participants with LS. * To assess the safety profile of treatment with naproxen or aspirin in participants with LS. * To assess the effect of treatment with naproxen or aspirin in normal mucosa, stool and periodontal microbiome in participants with LS. * To compare the effect of naproxen or aspirin on the abundance of T cells and other im-mune cell types in the normal colorectal mucosa, endometrium and peripheral blood of participants with LS. * To assess the symptoms of LS participants randomized to naproxen or aspirin.

Conditions

• T Cells
• Colorectal Cancer
• Lynch Syndrome

Interventions

Type	Name	Description
DRUG	Naproxen	Given by PO
DRUG	Aspirin	Given by PO

Timeline

• Start date: 2023-03-21
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2022-06-09
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study