SEMAGLUTIDE, WEIGHT LOSS, AND INTRAUTERINE THERAPY FOR FERTILITY-SPARING AND CONSERVATIVE TREATMENT FOR ENDOMETRIAL ATYPICAL HYPERPLASIA AND EARLY-STAGE, GRADE 1 ENDOMETRIOID ENDOMETRIAL CANCER
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Pathological Response Rate
研究概览
简要总结
The goal of this clinical trial is to learn if a combination treatment of a hormonal intrauterine device (LNG-IUD), semaglutide, and a structured weight loss program can treat endometrial atypical hyperplasia or grade 1 endometrioid endometrial cancer while preserving fertility in women of reproductive age with endometrial atypical hyperplasia (EAH) or FIGO grade 1 endometrioid endometrial cancer who wish to preserve their fertility. The main questions it aims to answer are:
- What proportion of participants achieve a complete pathological response after treatment?
- How durable is the response at 12 months?
- What effect does the treatment have on metabolic outcomes (weight, BMI, HbA1c) and quality of life?
Participants will:
- Receive an LNG-IUD
- Receive semaglutide 2.4mg
- Participate in a structured weight loss program
- Undergo hysteroscopy with endometrial sampling to assess treatment response
- Complete quality-of-life assessments at baseline, 6 months, and 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological Diagnosis: Histologically confirmed endometrial atypical hyperplasia or FIGO grade 1 endometrioid Endometrial Cancer
- •Imaging eligibility (for patients with endometrial cancer):
- •Depth of myometrial invasion <50% confirmed by MRI or disease limited to the endometrium
- •No evidence of extrauterine or metastatic disease on imaging.
- •Treatment Rationale (at least one of the following must apply):
- •Desire for future fertility: Patient expresses a documented desire to preserve the uterus and future reproductive function, with explicit acknowledgment that fertility-sparing treatment is not standard of care for endometrial cancer.
- •Medical inoperability: patients are considered a poor surgical candidate due to:
- •i. Class III obesity (BMI ≥40 kg/m²); or ii. ASA Physical Status Classification score ≥
- •Metabolic Profile: BMI ≥ 30 kg/m², or BMI 27-29.9 kg/m² with at least one weight-related comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease).
- •Progestin washout: patients with prior progestin exposure are eligible provided the following minimum washout periods have been observed.
- •Oral progestins: 7 days
- •Injectable, short acting: 14 days
- •Injectable, long acting: 6 months
- •Contraceptive implant: 28 days
- •LNG-IUD: 7 days after removal
排除标准
- •Age ≥18 years
- •Negative pregnancy test at screening
- •Ability to provide written informed consent and comply with study procedures
- •Willingness to undergo genetic counseling and MMR/IHC tumor profiling
- •Willingness and ability to participate in a structured weight loss program, including attendance at counseling sessions (in person or virtual) and adherence to dietary and physical activity goals.
研究组 & 干预措施
Combination Fertility-Sparing Treatment
Participants will receive a three-component combination intervention consisting of: (1) a levonorgestrel-releasing intrauterine device (LNG-IUD), inserted at baseline; (2) semaglutide 2.4 mg, administered per standard dosing schedule; and (3) a structured weight loss program. Participants will undergo hysteroscopy with endometrial sampling to assess pathological response. Treatment will be administered for 6 months of active intervention, followed by a 6-month follow-up period.
干预措施: Semaglutide (Wegovy) weekly injection (Drug)
Combination Fertility-Sparing Treatment
Participants will receive a three-component combination intervention consisting of: (1) a levonorgestrel-releasing intrauterine device (LNG-IUD), inserted at baseline; (2) semaglutide 2.4 mg, administered per standard dosing schedule; and (3) a structured weight loss program. Participants will undergo hysteroscopy with endometrial sampling to assess pathological response. Treatment will be administered for 6 months of active intervention, followed by a 6-month follow-up period.
干预措施: LNG-IUD (Progestin) (Device)
Combination Fertility-Sparing Treatment
Participants will receive a three-component combination intervention consisting of: (1) a levonorgestrel-releasing intrauterine device (LNG-IUD), inserted at baseline; (2) semaglutide 2.4 mg, administered per standard dosing schedule; and (3) a structured weight loss program. Participants will undergo hysteroscopy with endometrial sampling to assess pathological response. Treatment will be administered for 6 months of active intervention, followed by a 6-month follow-up period.
干预措施: Structured Weight Loss Program (Behavioral)
结局指标
主要结局
Pathological Response Rate
时间窗: 6 months
Pathological Response Rate (PRR) defined as the rate of regression of atypical hyperplasia or carcinoma on histopathological examination of the 6-month (end-of-treatment) hysteroscopic sample
次要结局
- Time to response(12 months)
- Adverse events(12 months)
- Durable response rate(12 months)
- Disease progression rate(12 months)
- Recurrence rate(12 months)
研究者
Aparna A. Kamat
MD
The Methodist Hospital Research Institute