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.
PRE-REGISTRATION: Postmenopausal women
PRE-REGISTRATION: Transvaginal ultrasound
PRE-REGISTRATION: Scheduled endometrial biopsy
PRE-REGISTRATION: Provide risk factor survey
PRE-REGISTRATION: Not postmenopausal person born with uterus
PRE-REGISTRATION: Atrophic endometrium
PRE-REGISTRATION: No uterus
PRE-REGISTRATION: Malignancy found
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood, urine, and endometrial tissue sample collection
Low-Dose Aspirin
DrugGiven PO
Patient Observation
Other interventionUndergo observation
Questionnaire Administration
Other interventionAncillary studies
Ultrasound Imaging
Procedure/SurgeryUndergo pelvic ultrasound
Change in prostaglandin E2 (PGE2)
Assessed by repeated tissue sampling of the endometrium and compared between treatment and observation groups. A linear mixed-effects model (LMM) will be used to compare the change in PGE2 levels obtained from paired endometrial sampling between two groups of patients (aspirin versus \[vs.\] no aspirin). The continuous time that elapses between sampling will be assessed together with the binary patient group (aspirin vs. no aspirin) to investigate the change in continuous PGE2 measurement.
Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial
Assessed at baseline (after consent to participate) using a questionnaire developed for this study: Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial. The survey consists of 7 questions evaluating motivation for participating, barriers to participating, and expectations and understanding of study outcomes. Questions can be answered with one of the listed multiple choice options or with an open-ended "other" option. Post-study data collection will be completed via interview using questions similar to the baseline survey. Results will be analyzed and reported descriptively.
Correlation of biomarkers with endometrial status
Biomarkers obtained from biospecimen samples will be assessed for correlation with endometrial status in women on low-dose aspirin versus those not taking low-dose aspirin (observational cohort). Biomarker data will be tested in LMMs for significant association with treatment group and change over time.
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