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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.
Must not have
Individuals with active gastroduodenal ulcer disease in the preceding 5 years.
Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had an active stomach or upper small intestine ulcer in the last 5 years.
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I have had a heart attack, stroke, or heart surgery in the last 5 years.
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I do not have uncontrolled kidney problems.
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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am willing to use reliable contraception.
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I do not have any uncontrolled illnesses that could interfere with the study.
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I have had surgery to remove my entire colon and rectum.
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My tumor has specific genetic changes in the MMR genes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2014 Phase 4 trial • 323 Patients • NCT015872746%
Nausea/ vomiting
5%
Stomach irritation
4%
Drowsiness
4%
Dizziness
3%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Alone
Opioid
Skeletal Muscle Relaxant
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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
3,066 Previous Clinical Trials
1,802,205 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,571 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,961 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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
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