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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05411718
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Naproxen — DRUG
    Given by PO
  • Aspirin — DRUG
    Given by PO

Study Details

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

Key Dates

Start date
Mar 21, 2023
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Naproxen
    Participants will take two (2) naproxen matching capsules by mouth 1 time every day, at about the same time each day
  • Active Comparator: Aspirin
    Participants will take two (2) aspirin matching capsules by mouth 1 time every day, at about the same time each day

Primary Outcome Measure

To establish the effect of naproxen or aspirin on the abundance of T cells and other immune [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Eduardo Vilar Sanchez, MD
Eduardo Vilar Sanchez, MD (PRINCIPAL_INVESTIGATOR)

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By specialty
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