The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

August 19, 2024 updated by: Samah Essam Saber Mahran, Cairo University

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • faculty of pharmacy Cairo university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metformin
(39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol
Drug: Metformin Hydrochloride 500 MG
Metformin 500mg tablets twice daily
No Intervention: Control
(39) patients taking cisplatin (70 mg/m2) gemcitabine (1000 mg/m2) (GC) protocol without metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine (SCr)
Time Frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.
12 week
Human Neutrophil gelatinase-associated lipocalin (NGAL)
Time Frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
12 week
Cystatin C
Time Frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
12 week
Estimated glomerular filtration rate (eGFR)
Time Frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
12 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Samar Farid, faculty of pharmacy Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 16, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL (3164)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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