Evaluating metformin's protective effects against kidney damage from cisplatin in bladder cancer patients
The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
This study is testing if the diabetes drug metformin can help protect the kidneys of bladder cancer patients from damage caused by cisplatin chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06215976 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the nephroprotective effects of metformin when used alongside cisplatin in patients diagnosed with muscle-invasive bladder carcinoma. The study will focus on determining whether metformin can mitigate kidney injury caused by cisplatin chemotherapy. Additionally, it will evaluate the safety of this combination treatment in chemotherapy-naïve patients with stable renal function. Participants will receive metformin hydrochloride at a dosage of 500 mg during the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are non-diabetic adults aged 18 to 65 with stable renal function and a diagnosis of bladder cancer who have not previously received chemotherapy.
Not a fit: Patients with a history of lactic acidosis, unstable renal function, or those taking other nephrotoxic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney health for bladder cancer patients undergoing cisplatin treatment.
How similar studies have performed: While the specific combination of metformin and cisplatin in this context is novel, previous studies have explored metformin's nephroprotective properties in other settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- faculty of pharmacy Cairo university — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Samah Essam Saber Mahran
- Email: samah.essam@pharma.cu.edu.eg
- Phone: 0201094164048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.