The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Phase 4

Recruiting

• Conditions: Muscle-Invasive Bladder Carcinoma
• Interventions: Drug: Metformin Hydrochloride 500 MG

• Registration Number: NCT06215976
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-12-16
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-22
• Primary Completion: 2024-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin Hydrochloride 500 MG	(39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Blood pH	12 week	to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any)
Blood Lactate Level	12 week	to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any)
HbA1C	12 week	to assess the safety of using cisplatin-metformin combination in bladder cancer patients
Body Mass Index	12 week	to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)
Body weight	12 week	to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)
FBG	12 week	to assess the safety of using cisplatin-metformin combination in bladder cancer patients receiving cisplatin

Trial Locations

Locations (1)

faculty of pharmacy Cairo university; 🇪🇬 Cairo, Egypt