The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- serum creatinine (SCr)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-diabetic adults of age between 18 to
- •Chemotherapy naïve patients diagnosed with bladder cancer.
- •Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2
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.
- •Any infection requiring hospitalization.
- •Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure.
- •Alcohol intake.
- •Respiratory failure.
- •Severe hepatic impairment (Child-Pugh class C).
- •Patients with metastasis.
Arms & Interventions
Metformin
(39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol
Intervention: Metformin Hydrochloride 500 MG (Drug)
Outcomes
Primary Outcomes
serum creatinine (SCr)
Time Frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.
Human Neutrophil gelatinase-associated lipocalin (NGAL)
Time Frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Cystatin C
Time Frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Estimated glomerular filtration rate (eGFR)
Time Frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Secondary Outcomes
- Blood pH(12 week)
- Blood Lactate Level(12 week)
- HbA1C(12 week)
- Body Mass Index(12 week)
- Body weight(12 week)
- FBG(12 week)
Investigators
Samah Essam Saber Mahran
Principal Investigator
Cairo University