Low Dose Aspirin to Lower Inflammation and Prevent Endometrial Cancer in Postmenopausal Women With Non-atrophic Endometrial Changes and Pain

NCT07281547 — Phase 4, Not yet recruiting, 20 participants, Mayo Clinic

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Mechanistic Randomized Controlled Feasibility Trial of Aspirin on Endometrium and Inflammatory Metabolites in Postmenopausal Women With Non-Atrophic Endometrial Changes

Registry	NCT07281547
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	20 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Endometrial Carcinoma
Interventions	Biospecimen Collection, Low-Dose Aspirin, Patient Observation, Questionnaire Administration, Ultrasound Imaging (Procedure, drug, other)
Dates	start 2027-02-12 (estimated), primary completion 2028-06-11 (estimated), completion 2028-06-11 (estimated), first posted 2025-12-15, last updated 2026-08-05
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Arm I (low dose aspirin)	Experimental	Procedure: Biospecimen Collection; Drug: Low-Dose Aspirin; Other: Questionnaire Administration; Procedure: Ultrasound Imaging	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.
Arm II (observation)	Active comparator	Procedure: Biospecimen Collection; Other: Patient Observation; Other: Questionnaire Administration; Procedure: Ultrasound Imaging	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.

Biospecimen Collection (Procedure), also known as Biological Sample Collection, Biospecimen Collected, Specimen Collection: Undergo blood, urine, and endometrial tissue sample collection
Low-Dose Aspirin (Drug), also known as Baby Aspirin: Given PO
Patient Observation (Other), also known as Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting: Undergo observation
Questionnaire Administration (Other): Ancillary studies
Ultrasound Imaging (Procedure), also known as 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US: Undergo pelvic ultrasound

+Outcome measures

Primary outcomes

Change in prostaglandin E2 (PGE2) [Baseline to 6 weeks]: 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.

Secondary outcomes

Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial [Baseline to 6 weeks]: 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.

Other outcomes

Correlation of biomarkers with endometrial status [Baseline to 42 days]: 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.

+Eligibility

Sex: Female, accepts healthy volunteers

Inclusion Criteria:

* PRE-REGISTRATION: Postmenopausal women
* PRE-REGISTRATION: Transvaginal ultrasound
* PRE-REGISTRATION: Scheduled endometrial biopsy
* PRE-REGISTRATION: Provide risk factor survey
* REGISTRATION: Postmenopausal (defined clinically by no period for over 1 year or postmenopausal follicle-stimulating hormone \[FSH\], estradiol, or anti-Mullerian hormone \[AMH\] levels due to natural, medical, or surgical causes)
* REGISTRATION: Have pain (an indicator of inflammation) and other findings warranting endometrial sampling (postmenopausal bleeding \[PMB\], incidentally noted thickened endometrium > 4mm on ultrasound, obesity, fibroids)
* REGISTRATION: Capable of providing informed consent
* REGISTRATION: Understands English or Spanish language for consent and questionnaires
* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
* REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
* REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
* REGISTRATION: Willingness to provide mandatory urine sample for correlative research

Exclusion Criteria:

* PRE-REGISTRATION: Not postmenopausal person born with uterus
* PRE-REGISTRATION: Atrophic endometrium
* PRE-REGISTRATION: No uterus
* PRE-REGISTRATION: Malignancy found
* REGISTRATION: Patients with previous hysterectomy (removal of the uterus)
* REGISTRATION: Atrophic endometrium on endometrial sampling performed clinically
* REGISTRATION: Patients from outside the Mayo Clinic Comprehensive Cancer Center (MCCCC) area
* REGISTRATION: Clinically contraindicated to discontinue use of anticoagulation other than aspirin
* REGISTRATION: Contraindication to use of nonsteroidal anti-inflammatory drugs (NSAIDs) or previous adverse reaction or intolerance to NSAIDs
* REGISTRATION: History of uterine, cervical, or ovarian cancers or precancers (endometrial hyperplasia, cervical dysplasia, fallopian tube intraepithelial carcinoma)

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Florida	Jacksonville, Florida	United States

+Investigators

Christopher C. DeStephano, MD, MPH, Principal investigator, Mayo Clinic