Mechanistic Randomized Controlled Feasibility Trial of Aspirin on Endometrium and Inflammatory Metabolites in Postmenopausal Women With Non-Atrophic Endometrial Changes
Mayo Clinic
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.
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- Yes
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 thic…
Interventions
- ProcedureBiospecimen Collection
Undergo blood, urine, and endometrial tissue sample collection
- DrugLow-Dose Aspirin
Given PO
- OtherPatient Observation
Undergo observation
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureUltrasound Imaging
Undergo pelvic ultrasound
Location
- Mayo Clinic in FloridaJacksonville, Florida