The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-12-30

Brief Summary

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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

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Detailed Description

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Conditions

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Muscle-Invasive Bladder Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Metformin

(39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride 500 MG

Intervention Type DRUG

Metformin 500mg tablets twice daily

Control

(39) patients taking cisplatin (70 mg/m2) gemcitabine (1000 mg/m2) (GC) protocol without metformin

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metformin Hydrochloride 500 MG

Metformin 500mg tablets twice daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No