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

Phase 4Not Yet RecruitingNCT07281547

Mayo Clinic25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Endometrial Carcinoma

Interventions

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 6 weeks

Secondary Outcomes

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.