Sulindac for Pancreatic Cancer Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if sulindac, a type of medication, can prevent the progression of certain pre-cancerous growths in the pancreas called intraductal papillary mucinous neoplasms (IPMNs). Participants will receive either sulindac or a placebo, with regular monitoring through scans and endoscopies, for up to three years. The trial seeks individuals diagnosed with high-risk IPMN, which may include features like larger cysts or changes in the pancreatic duct. As a Phase 2 trial, this research measures how well sulindac works in an initial, smaller group of people, offering a chance to contribute to important advancements in pancreatic health.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot participate if you take a systemic corticosteroid or NSAID more than 3 times a week. If you are on these medications, you may need to stop or reduce them to join the trial.
Is there any evidence suggesting that sulindac is likely to be safe for humans?
Research has shown that sulindac has been safely used in clinical trials for various health issues. While specific safety information for its use in preventing pancreatic cancer is not available, its use in other trials suggests it is generally safe. Most people taking sulindac do not experience serious side effects. However, some might encounter mild side effects. Discussing potential risks with a doctor is important before joining a trial.12345
Why do researchers think this study treatment might be promising for pancreatic cancer prevention?
Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy and radiation, sulindac is being explored for its potential to prevent pancreatic cancer altogether. Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) that may work differently by reducing inflammation, which is thought to play a role in cancer development. Researchers are excited because if sulindac proves effective, it could offer a proactive approach to cancer prevention, potentially reducing the need for more aggressive treatments later on.
What evidence suggests that sulindac might be an effective treatment for pancreatic cancer prevention?
Research has shown that sulindac, a drug that reduces inflammation, might help prevent pancreatic cancer. Studies in mice found that sulindac can slow the growth of pancreatic tumors by affecting a specific protein linked to cancer. Additionally, sulindac has prevented cells from becoming cancerous, suggesting it might lower the risk of pancreatic cancer in people with certain pancreatic growths. This trial will compare sulindac with a placebo to evaluate its effectiveness in humans. While these early results are promising, human trials are needed to confirm its efficacy.12367
Who Is on the Research Team?
Peter Allen, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for adults aged 21-85 with high-risk IPMN of the pancreas, who are medically fit for an endoscopic ultrasound and can undergo imaging studies. Women able to have children must use contraception during the study. Exclusions include heart failure, recent cancer treatments, certain surgical histories, severe drug reactions to contrast agents or NSAIDs, recent heart attacks or bypass surgery, and ongoing renal insufficiency or other conditions that conflict with sulindac use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sulindac or placebo twice daily for up to 3 years with regular assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Sulindac
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Johns Hopkins University
Collaborator
Massachusetts General Hospital
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
National Cancer Institute (NCI)
Collaborator