Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

A phase IIa randomized, double-blinded clinical trial of naproxen or aspirin for cancer immune interception in Lynch syndrome

Clinical Trial Details

This study aims to learn more about the effects of naproxen and aspirin on the normal colon in people with Lynch syndrome. By doing this study, the study team hopes to gather information on the safety and effectiveness of naproxen and/or aspirin for the use of cancer immune interception in Lynch syndrome. Naproxen or aspirin may help to prevent the development of cancerous cells in the colon.   
  
Naproxen and aspirin are both approved by the U.S. Food and Drug Administration (FDA) to relieve pain and fever, however it is considered investigational to give naproxen or aspirin to patients with Lynch syndrome.

Participants will be randomly assigned to receive either naproxen or aspirin. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Participants will take either naproxen or aspirin capsules by mouth 1 time each day. There will also be study visits and study calls throughout the duration of the study.   

Total study participation will last about one year.

Key Eligibility: 
  1. Age 18 years or older with a diagnosis of Lynch syndrome as determined based on phenotypic and/or genetic criteria (following diagnosis HNPCC, Lynch syndrome, Hereditary Non-Polyposis Colon Cancer, PMS2 mutation (MLH1, MSH2, MSH6, PMS2, EPCAM).
  2. Must have no active or recurrent invasive malignancy
  3. Must be at least 6 months from receipt of prior cancer-directed therapy, if any
  4.  Must have an intact rectosigmoid colon. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2206024932

ClinicalTrials.gov:

NCT05411718

Sponsor:

2022-0117

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease