Effect of Metformin on Endometrial Thickness in Postmenopausal Breast Cancer Patients Receiving Tamoxifen: A Randomized Clinical Trial in Iraq.
- Conditions
- Breast CancerEndometrial Hyperplasia and Endometrial Cancers
- Interventions
- Registration Number
- NCT07145827
- Lead Sponsor
- Uruk University
- Brief Summary
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:
1. Does metformin decrease endometrial thickness in women receiving tamoxifen?
2. 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:
1. Take metformin daily along with tamoxifen, or take tamoxifen with placebo.
2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- Postmenopausal Female patients (amenorrhea ≥ 12 months).
- Histologically proven ER+ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tamoxifen + Metformin Metfomin 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. Tamoxifen + Metformin tamoxifen 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. Tamoxifen + Placebo tamoxifen 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. Tamoxifen + Placebo Placebo matching Metformin 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.
- Primary Outcome Measures
Name Time Method Change in endometrial thickness Baseline, 3 months, 6 months, 9 months, and 12 months from enrollment Endometrial thickness will be measured using transabdominal ultrasound (in mm) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Baghdad Medical City / Department of Oncology
🇮🇶Baghdad, Baghdad Governorate, Iraq
Baghdad Medical City / Department of Oncology🇮🇶Baghdad, Baghdad Governorate, Iraq