The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Muscle-Invasive Bladder Carcinoma Clinical Trial

Official title:

The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215976
• Other study ID #: CL (3164)
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: Samah Essam Saber Mahran
• Phone: 0201094164048
• Email: samah.essam[@]pharma.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle-Invasive Bladder Carcinoma
• Urinary Bladder Neoplasms

Intervention

Drug:
• Metformin Hydrochloride 500 MG
Metformin 500mg tablets twice daily

Locations

Country	Name	City	State
Egypt	faculty of pharmacy Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum creatinine (SCr)	to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.	12 week
Primary	Human Neutrophil gelatinase-associated lipocalin (NGAL)	to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity	12 week
Primary	Cystatin C	to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity	12 week
Primary	Estimated glomerular filtration rate (eGFR)	to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity	12 week
Secondary	FBG	to assess the safety of using cisplatin-metformin combination in bladder cancer patients receiving cisplatin	12 week
Secondary	HbA1C	to assess the safety of using cisplatin-metformin combination in bladder cancer patients	12 week
Secondary	Body weight	to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)	12 week
Secondary	Body Mass Index	to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)	12 week
Secondary	Blood pH	to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any)	12 week
Secondary	Blood Lactate Level	to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any)	12 week