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The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | (39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol |
|
| Control | No Intervention | (39) patients taking cisplatin (70 mg/m2) gemcitabine (1000 mg/m2) (GC) protocol without metformin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Hydrochloride 500 MG | Drug | Metformin 500mg tablets twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum creatinine (SCr) | to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity. | 12 week |
| Human Neutrophil gelatinase-associated lipocalin (NGAL) | to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity | 12 week |
| Cystatin C | to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity | 12 week |
| Estimated glomerular filtration rate (eGFR) | to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| FBG | to assess the safety of using cisplatin-metformin combination in bladder cancer patients receiving cisplatin | 12 week |
| HbA1C | to assess the safety of using cisplatin-metformin combination in bladder cancer patients |
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Inclusion Criteria:
Exclusion Criteria:
Patients with history of lactic acidosis.
Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin).
Unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dL or greater suddenly in 48 hours according to the acute kidney injury network (AKIN) classification
Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock).
Severe infection and sepsis.
Alcohol intake.
Respiratory failure.
Severe hepatic impairment (Child-Pugh class C).
Patients with metastasis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samah Essam Saber Mahran | Contact | 0201094164048 | samah.essam@pharma.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Samar Farid | faculty of pharmacy Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of pharmacy Cairo university | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40319155 | Derived | Mahran SE, Salem SE, Sabry NA, Farid SF. The nephroprotective effect of metformin with cisplatin in bladder cancer: randomized clinical trial. Int Urol Nephrol. 2025 Nov;57(11):3611-3624. doi: 10.1007/s11255-025-04505-2. Epub 2025 May 3. |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| 12 week |
| Body weight | to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss) | 12 week |
| Body Mass Index | to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss) | 12 week |
| Blood pH | to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any) | 12 week |
| Blood Lactate Level | to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any) | 12 week |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |