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

Mayo Clinic

Status and phase: Not yet enrolling; Phase 4

Conditions: Endometrial Carcinoma

Treatments: Procedure: Biospecimen Collection; Drug: Low-Dose Aspirin; Other: Patient Observation; Procedure: Ultrasound Imaging; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT07281547

NCI-2025-08686 (Registry Identifier)

MC240602 (Other Identifier)

24-006515 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Female

Volunteers: 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Arm I (low dose aspirin)

Experimental group

Description:

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.

Treatment:

Procedure: Ultrasound Imaging

Other: Questionnaire Administration

Drug: Low-Dose Aspirin

Procedure: Biospecimen Collection

Arm II (observation)

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasound Imaging

Other: Questionnaire Administration

Other: Patient Observation

Procedure: Biospecimen Collection