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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen + Metformin | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metfomin | Drug | Metformin Tab. 500mg twice daily for 12 months (titrated to tolerance if needed). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in endometrial thickness | 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. | Baseline, 3 months, 6 months, 9 months, and 12 months from enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghasak Kais Abdulhussain, BSc, MSc, PhD (Pharmacology) | Uruk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baghdad Medical City / Department of Oncology | Baghdad | Baghdad Governorate | 10045 | Iraq |
De-identified participant-level data, including endometrial thickness measurements, baseline demographics, and follow-up data relevant to primary outcomes.
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Upon publication of the trial result on open access repository.
Access will be open to researchers and the public via a free, open-access data repository, with a DOI provided in the publication. Data will be de-identified to protect participant privacy.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004714 | Endometrial Hyperplasia |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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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.
| tamoxifen | Drug | Standard prescribed oncological dose. |
|
| Placebo matching Metformin | Drug | An inert, film-coated tablet identical in appearance and packaging to metformin 500 mg (same size, shape, color, coating, weight, and dosing schedule), manufactured without active ingredient using standard excipients (e.g., microcrystalline cellulose, starch/croscarmellose, povidone, magnesium stearate) and identical film coat (e.g., hypromellose, polyethylene glycol, titanium dioxide). Packaged in sealed blisters to minimize odor/taste cues. Dispensed by the investigational pharmacy per randomization; to be taken twice daily" |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |