Effect of Metformin on Endometrial Thickness in Postmenopausal Breast Cancer Patients Receiving Tamoxifen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in endometrial thickness
研究概览
简要总结
The goal of this clinical trial is to learn if metformin can reduce the increase in endometrial thickness caused by tamoxifen in women with estrogen-positive breast cancer taking tamoxifen for more than 1 year. It will also learn about the safety of taking metformin with tamoxifen. The main questions it aims to answer are:
- Does metformin decrease endometrial thickness in women receiving tamoxifen?
- What medical problems do participants have when taking metformin with tamoxifen?
Researchers will compare tamoxifen plus metformin to tamoxifen plus placebo to see if metformin works to reduce endometrial thickness compared to placebo patients.
Participants will:
- Take metformin daily along with tamoxifen, or take tamoxifen with placebo.
- Acquire baseline assessment and then visit the clinic at 3 months, 6 months, 9 months and 12 months for checkups and trans abdominal ultrasound test for endometrial thickness, and to be monitored for any side effects or complications.
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
- Double (Participant, Outcomes Assessor)
盲法说明
This is a double-blind study. Neither the participants nor the ultrasound operator assessing the primary outcome (endometrial thickness) will be aware of the treatment allocation. Study medication and placebo will be identical in appearance and packaging. Randomization codes will be securely held and only revealed after completion of data analysis, unless required for patient safety.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal Female patients (amenorrhea ≥ 12 months).
- •Histologically proven (Estrogen-positive) breast cancer.
- •Completed all required surgery and/or chemotherapy (if indicated)
- •On adjuvant tamoxifen for at least 1 year.
- •Accepts to enroll in the study
排除标准
- •Refusing to enroll in the study
- •Ongoing or History of: endometrial or ovarian malignancy
- •Concurrent hormonal therapy that might affect endometrial thickness
- •Concurrent Diabetes mellitus in which metformin is prescribed.
- •Known hypersensitivity or severe intolerance to metformin
研究组 & 干预措施
Tamoxifen + Metformin
Participants in this arm (n=30) will continue taking the standard oncological tamoxifen dose as prescribed and receive an addition of metformin 500mg twice daily, titrated to tolerance, during the 12-month study period.
干预措施: Metfomin (Drug)
Tamoxifen + Metformin
Participants in this arm (n=30) will continue taking the standard oncological tamoxifen dose as prescribed and receive an addition of metformin 500mg twice daily, titrated to tolerance, during the 12-month study period.
干预措施: tamoxifen (Drug)
Tamoxifen + Placebo
Participants in this arm (n=30) will continue to receive the standard oncological dose of tamoxifen as prescribed, in addition to a placebo tablet matching the shape size and color of metformin tablet twice daily during the 12 months study period; they will act as the control group.
干预措施: tamoxifen (Drug)
Tamoxifen + Placebo
Participants in this arm (n=30) will continue to receive the standard oncological dose of tamoxifen as prescribed, in addition to a placebo tablet matching the shape size and color of metformin tablet twice daily during the 12 months study period; they will act as the control group.
干预措施: Placebo matching Metformin (Drug)
结局指标
主要结局
Change in endometrial thickness
时间窗: Baseline, 3 months, 6 months, 9 months, and 12 months from enrollment
Endometrial thickness will be measured using transabdominal ultrasound (in millimeters) by a trained radiologist. The primary outcome is the difference in endometrial thickness between the metformin plus tamoxifen group and the placebo plus tamoxifen control group.
次要结局
未报告次要终点
研究者
Ghasak kais Abdulhussain
Lecturer in department of Pharmacology (B.Sc , M.Sc, Ph.D) / College of Pharmacy
Uruk University