A Study Comparing Two Anti-inflammatory Medications Naproxen or Aspirin for Cancer Prevention in Lynch Syndrome

About the Study

The trial is enrolling people with Lynch syndrome. On average, the length of this study will last one year from the start of enrollment to completion. The study will measure  the effect of naproxen or aspirin on the immune cells in the gastrointestinal tract of people with Lynch syndrome. The trial will also evaluate any symptoms from the medications and any other changes of the colon and rectum.

What the Study Involves

This clinical trial is for people with Lynch Syndrome who have no active cancer. People who have never had a cancer diagnosis may participate. People who have previously been diagnosed with cancer may participate if they completed treatment at least 6 months prior to joining the study, and they have enough of their colon and/or rectum remaining to undergo colonoscopy or sigmoidoscopy.  People will be randomly divided into one of two groups:

Group 1: People in this group will:

• take two naproxen capsules by mouth once daily at approximately the same time each day.
• have one procedure using (flexible sigmoidoscopy or colonoscopy) with biopsies.
• 12 months later have a second procedure using flexible sigmoidoscopy.

Group 2: People in this group will:

• take two aspirin capsules by mouth once daily at approximately the same time each day.
• have one procedure using (flexible sigmoidoscopy or colonoscopy) with biopsies.
• 12 months later have a second procedure using flexible sigmoidoscopy.

Study Site

Texas

Houston
MD Anderson Cancer Center                                                                                                           
Principal Investigator/Contact: Eduardo Vilar Sanchez, MD evilar@mdanderson.org

People 18 years of age or older may participate if they:

• have Lynch syndrome.
• are cancer free for six months.
• are six months out from any cancer treatments including hormonal therapy.
• are able to have a sigmoidoscopy procedure.
• are willing to have 2 procedures with biopsies around one year apart.
• are willing to refrain from using additional aspirin or Non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX)-inhibitors for the duration of the trial.
• agree to use adequate contraception for the duration of the study participation if they are of child-bearing age.
• willing to undergo yearly standard of care screening colonoscopy for the duration of the trial.

People who:

• are under the age of 18
• received scheduled NSAIDs or COX-inhibitors of any kind for more than three days during any time within the two weeks prior to eligibility screening visit.
• have had all or part of their colon or rectum removed.
• have had a blood transfusion as a result of a gastrointestinal (GI) bleed, perforation (tear), or obstruction. If any of these events were the result of cancer in the GI tract and the cancer has since been removed, the patient may still be eligible for the trial.
• have a history of a heart attack, stroke, coronary-artery bypass graft, invasive coronary revascularization, which is a procedure that restores blood to the heart, in the last five years.
• are not willing or able to stop medications required to participate in this study such as certain antidepressants, blood thinners, seizure medications, antibiotics, antifungals, aspirin and ibuprofen. The study team will review your medications and help you determine if you are eligible to participate in this study. For a full list of medications you would need to stop, visit here.
• have kidney issues or kidney failure
• have a history of allergic reactions to naproxen or aspirin
• have uncontrolled, recurring illness or active infections, uncontrolled high blood pressure, congestive heart failure, pain in the chest, irregular heart rate, or a mental illness that could limit the ability to follow the study requirements.
• are pregnant, breast-feeding, or women of childbearing potential who are unwilling to use a reliable contraceptive method.