Mechanistic Randomized Controlled Feasibility Trial of Aspirin on Endometrium and Inflammatory Metabolites in Postmenopausal Women With Non-Atrophic Endometrial Changes
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in prostaglandin E2 (PGE2)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Arm II (observation)
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.
干预措施: Patient Observation (Other)
Arm II (observation)
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.
干预措施: Questionnaire Administration (Other)
Arm II (observation)
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.
干预措施: Ultrasound Imaging (Procedure)
Arm I (low dose aspirin)
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.
干预措施: Biospecimen Collection (Procedure)
Arm I (low dose aspirin)
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.
干预措施: Questionnaire Administration (Other)
Arm I (low dose aspirin)
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.
干预措施: Ultrasound Imaging (Procedure)
Arm II (observation)
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.
干预措施: Biospecimen Collection (Procedure)
Arm I (low dose aspirin)
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.
干预措施: Low-Dose Aspirin (Drug)
结局指标
主要结局
Change in prostaglandin E2 (PGE2)
时间窗: 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.
Change in prostaglandin E2 (PGE2)
时间窗: 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.
次要结局
- Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial(Baseline to 6 weeks)