This phase IV trial studies whether low dose aspirin can be used to lower inflammation and prevent endometrial cancer in postmenopausal women with changes in the endometrial tissue that are not related to thinning (non-atrophic endometrial changes) and pain. As people age, there is an accumulation of fats, cell death, and inflammation, which causes a surge of pro-cancer-causing events. It is thought that there are several factors involved in the development of endometrial cancer, but that managing the inflammation may address the root cause. Low dose aspirin is aspirin that contains a lower dose than a standard adult tablet. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. Aspirin belongs to the family of drugs called nonsteroidal anti-inflammatory agents. It is also being studied in cancer prevention. Giving low dose aspirin may be an effective way to lower inflammation and prevent endometrial cancer in postmenopausal women with non-atrophic endometrial changes and pain.
Additional locations may be listed on ClinicalTrials.gov for NCT07281547.
Locations matching your search criteria
United States
Florida
Jacksonville
Mayo Clinic in FloridaStatus: Approved
Contact: Christopher C. DeStephano
Phone: 904-953-2230
PRIMARY OBJECTIVE:
I. To evaluate endometrial prostaglandin E2 (PGE2) levels in patients randomized to low dose aspirin (81 mg/day) versus observation at baseline and at the completion of the trial.
SECONDARY OBJECTIVES:
I. To determine facilitators and barriers for participation in cancer interception clinical trials among women who are without cancer.
II. Correlation of blood, urine, and endometrial methylation markers, inflammatory metabolites, and adipokines to endometrial status in women on low-dose aspirin versus those not taking low-dose aspirin (the observational control).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive low dose aspirin orally (PO) once daily (QD) for up to 42 days in the absence of unacceptable toxicity.
ARM II: Participants undergo observation for up to 42 days in the absence of unacceptable toxicity.
Additionally, all patients undergo pelvic ultrasound and blood, urine, and endometrial tissue sample collection throughout the trial.
After completion of study intervention, patients are followed up at 14 days.
Lead OrganizationMayo Clinic in Florida
Principal InvestigatorChristopher C. DeStephano
