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Nonsteroidal Anti-inflammatory Drug
Naproxen + Aspirin for Lynch Syndrome
Phase 2
Recruiting
Led By Eduardo Vilar-Sanchez, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years.
Willing to undergo yearly standard of care screening colonoscopy for the duration of the clinical trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is studying the effects of two drugs, naproxen and aspirin, on the normal colon in people with Lynch Syndrome.
Who is the study for?
Adults over 18 with Lynch Syndrome, a condition predisposing them to colorectal cancer, can join this trial. They must have normal organ and marrow function, not be pregnant or breastfeeding, agree to use contraception if applicable, and refrain from NSAIDs during the trial. Those with recent cancers or major surgeries are excluded.Check my eligibility
What is being tested?
The study is testing whether naproxen or aspirin could help prevent cancer in people with Lynch Syndrome by looking at their colon's response. Participants will randomly receive either drug and undergo regular colon examinations to track changes.See study design
What are the potential side effects?
Naproxen and aspirin may cause gastrointestinal issues like ulcers or bleeding, allergic reactions for those sensitive to NSAIDs, kidney problems in susceptible individuals, and increased risk of heart-related events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am willing to have a yearly colonoscopy for the trial period.
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I have Lynch syndrome, confirmed by genetic testing or my medical history.
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Part of my lower colon or rectum is intact and can be examined with an endoscope.
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You must have normal levels of red and white blood cells, platelets, and other blood indicators, as well as normal kidney and liver function.
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I agree not to take aspirin, NSAIDs, or COX-inhibitors during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish the effect of naproxen or aspirin on the abundance of T cells and other immune
Side effects data
From 2014 Phase 4 trial • 323 Patients • NCT015872746%
Nausea/ vomiting
5%
Stomach irritation
4%
Dizziness
4%
Drowsiness
3%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Alone
Opioid
Skeletal Muscle Relaxant
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NaproxenExperimental Treatment1 Intervention
Participants will take two (2) naproxen matching capsules by mouth 1 time every day, at about the same time each day
Group II: AspirinActive Control1 Intervention
Participants will take two (2) aspirin matching capsules by mouth 1 time every day, at about the same time each day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,356 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,836 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,092 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to have two lower GI endoscopies with biopsies, one year apart.I have not had an active stomach or upper small intestine ulcer in the last 5 years.I am mostly able to care for myself and carry out daily activities.I have had a heart attack, stroke, or heart surgery in the last 5 years.I do not have uncontrolled kidney problems.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am willing to use reliable contraception.I am 18 years old or older.It's been over 6 months since my last cancer treatment.I am willing to stop taking certain medications like ibuprofen, aspirin, and others 7 days before starting the study treatment.I haven't taken NSAIDs or COX-inhibitors for more than 3 days in the last 2 weeks, except for low-dose aspirin which I can stop.I have had serious GI issues due to bleeding, perforation, or blockage but am eligible if these were caused by a now-removed cancer.I do not have any uncontrolled illnesses that could interfere with the study.I agree to use birth control and take pregnancy tests as required for the study.I have had surgery to remove my entire colon and rectum.I am willing to have a yearly colonoscopy for the trial period.I have Lynch syndrome, confirmed by genetic testing or my medical history.Part of my lower colon or rectum is intact and can be examined with an endoscope.I am an adult, at least 18 years old, and eligible for this trial.You must have normal levels of red and white blood cells, platelets, and other blood indicators, as well as normal kidney and liver function.My tumor has specific genetic changes in the MMR genes.You have had allergic reactions to naproxen or aspirin in the past.I have been cancer-free for at least 6 months.I agree not to take aspirin, NSAIDs, or COX-inhibitors during the trial.This is not an exclusion criterion, but rather a description of minority recruitment strategies for the clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Naproxen
- Group 2: Aspirin
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Naproxen cleared regulatory scrutiny from the FDA?
"Naproxen has been given a score of 2 on our team's scale, as the drug is currently being tested in phase 2 trials. This implies that there exists some data confirming its safety but none to prove efficacy."
Answered by AI
Are there any vacancies for potential participants in this research project?
"It appears that clinicaltrials.gov has not recorded any new information regarding this trial since November 23rd 2022, suggesting it is no longer actively recruiting patients. However, there are 1,990 other trials currently open to participants at the moment."
Answered by AI
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