Low-Dose Aspirin for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a low dose of aspirin can reduce inflammation and prevent endometrial cancer in postmenopausal women. The research targets those with non-atrophic endometrial changes and pain, conditions that inflammation might cause to progress to cancer. Participants will either take low-dose aspirin or be observed for 42 days, undergoing tests like pelvic ultrasounds and providing blood, urine, and tissue samples. Postmenopausal women experiencing pain and diagnosed with changes in the uterine lining may be suitable for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot participate if it's clinically unsafe for you to stop using blood thinners other than aspirin. It's best to discuss your specific medications with the trial team.
What is the safety track record for low-dose aspirin?
Research has shown that low-dose aspirin is usually safe for most people. Studies have explored its use in various areas, including cancer prevention. For instance, one study found that women with endometrial cancer who took low-dose aspirin had better survival rates, suggesting it might help reduce the risk or slow cancer progression.
Aspirin is also commonly used to relieve pain and reduce inflammation. The FDA has approved it for other uses, such as lowering the risk of heart attacks and strokes, indicating its general safety. However, like any medicine, aspirin can cause side effects, such as stomach upset or an increased risk of bleeding.
In this trial, participants will take low-dose aspirin for up to 42 days and will be closely monitored for any side effects. This careful monitoring helps address any issues quickly. Overall, evidence supports that low-dose aspirin is generally safe for most people when used correctly.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for endometrial cancer, which often include surgery, radiation, and chemotherapy, low-dose aspirin offers a simple, non-invasive alternative. Researchers are excited about this treatment because aspirin has anti-inflammatory properties that may help slow down cancer cell growth. Additionally, aspirin is already widely used and well-understood, making it potentially safer and more accessible for patients. This novel approach could lead to a less aggressive treatment option with fewer side effects.
What evidence suggests that low-dose aspirin might be an effective treatment for endometrial cancer?
Research suggests that low-dose aspirin might reduce the risk of developing endometrial cancer. A review of several studies has found a link between aspirin use and a lower chance of developing this cancer. One study showed that people with endometrial cancer who took aspirin and received treatment had better survival rates. However, some studies did not find a strong connection between aspirin use and improved cancer outcomes. In this trial, participants in one arm will receive low-dose aspirin, while those in another arm will undergo observation. While aspirin seems promising, results have been mixed, and more research is needed to confirm its effectiveness.12345
Who Is on the Research Team?
Christopher C. DeStephano, MD, MPH
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for postmenopausal women with non-atrophic endometrial changes and pain, which could lead to endometrial or uterine cancer. Participants should not have conditions that exclude them from the study, but specific exclusion criteria are not listed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low dose aspirin or undergo observation for up to 42 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low-Dose Aspirin
Trial Overview
The trial is testing if low dose aspirin can reduce inflammation and prevent endometrial cancer in participants. It includes taking aspirin, providing biospecimens, undergoing observation and ultrasound imaging, and filling out questionnaires.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive low dose aspirin PO QD for up to 42 days in the absence of unacceptable toxicity. Additionally, patients undergo pelvic ultrasound and blood, urine, and endometrial tissue sample collection throughout the trial.
Participants undergo observation for up to 42 days in the absence of unacceptable toxicity. Additionally, patients undergo pelvic ultrasound and blood, urine, and endometrial tissue sample collection throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Association of Low-Dose Aspirin and Survival of Women ...
Our results suggest that low-dose aspirin use is associated with improved survival outcomes in women with endometrial cancer, especially in those who are young, ...
2.
gynecologiconcology-online.net
gynecologiconcology-online.net/article/S0090-8258(16)30209-8/fulltextEffect of low-dose aspirin on survival outcome ...
Aspirin use in patients who received postoperative whole pelvic radiotherapy was associated with improved 5-year DFS rate (88.2% vs 61.5%, adjusted-HR 0.19, 95% ...
Aspirin use and endometrial cancer risk: a meta-analysis and ...
Our results suggest that the use of aspirin was associated with a reduced risk of endometrial cancer, and the reduced risk was closely related to the high- ...
Association of aspirin and ibuprofen use with endometrial ...
Here, the authors showed that ibuprofen use reduced EC risk, whereas no reduction in risk was observed with aspirin. The analysis used data from ...
Aspirin use and endometrial cancer risk and survival
This study found no association between low-dose aspirin use and endometrial cancer specific survival (HR 0.91, 95% CI 0.69–1.20) [84].
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