Muscle-Invasive Bladder Carcinoma
Conditions
Keywords
Metformin, cisplatin, nephroprotective effect, nephrotoxicity, bladder cancer
Brief summary
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: * To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer. * To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer
Interventions
Metformin 500mg tablets twice daily
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Non-diabetic adults of age between 18 to 65. 2. Chemotherapy naïve patients diagnosed with bladder cancer. 3. Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2
Exclusion criteria
1. Patients with history of lactic acidosis. 2. Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin). 3. 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 4. Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock). 5. Severe infection and sepsis. * Any infection requiring hospitalization. * Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure. 6. Alcohol intake. 7. Respiratory failure. 8. Severe hepatic impairment (Child-Pugh class C). 9. Patients with metastasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum creatinine (SCr) | 12 week | to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity. |
| Human Neutrophil gelatinase-associated lipocalin (NGAL) | 12 week | to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity |
| Cystatin C | 12 week | to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity |
| Estimated glomerular filtration rate (eGFR) | 12 week | to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FBG | 12 week | to assess the safety of using cisplatin-metformin combination in bladder cancer patients receiving cisplatin |
| HbA1C | 12 week | to assess the safety of using cisplatin-metformin combination in bladder cancer patients |
| Blood Lactate Level | 12 week | to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any) |
| Body weight | 12 week | to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss) |
| Body Mass Index | 12 week | to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss) |
| Blood pH | 12 week | to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any) |
Countries
Egypt
Contacts
Primary ContactSamah Essam Saber Mahran
Outcome results
None listed