Pantoprazole in Cisplatin Nephrotoxicity

Phase 3

Recruiting

• Conditions: Oncology
• Interventions: Other: Standard hydration; Drug: Pantoprazole high dose; Drug: Pantoprazole low dose; Drug: Cisplatin

• Registration Number: NCT04217512
• Lead Sponsor: Sherief Abd-Elsalam

Brief Summary

Pantoprazole in Cisplatin Nephrotoxicity

Detailed Description

Pantoprazole in Cisplatin NephrotoxicityPantoprazole in Cisplatin Nephrotoxicity. Is it protective?

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-12-29
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-02
• Last Update Submitted: 2020-01-02
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03
• Primary Completion: 2030-12-01
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with head and neck cancer

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Exclusion Criteria

• GFR less than 59.
• DM
• Elevated liver enzymes more than 3 fold.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard hydration alone	Standard hydration	Cisplatin with standard hydration
Pantoprazole Low dose	Standard hydration	Cisplatin with standard hydration with pantoprazole 0.6 mg/kg
Pantoprazole high dose	Pantoprazole high dose	Cisplatin with standard hydration with pantoprazole 1.6 mg/kg
Pantoprazole high dose	Standard hydration	Cisplatin with standard hydration with pantoprazole 1.6 mg/kg
Pantoprazole Low dose	Pantoprazole low dose	Cisplatin with standard hydration with pantoprazole 0.6 mg/kg
Standard hydration alone	Cisplatin	Cisplatin with standard hydration
Pantoprazole high dose	Cisplatin	Cisplatin with standard hydration with pantoprazole 1.6 mg/kg
Pantoprazole Low dose	Cisplatin	Cisplatin with standard hydration with pantoprazole 0.6 mg/kg

Primary Outcome Measures

Name	Time	Method
Number of patients with no renal toxicity	6 months	The number of patients with no renal toxicity

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt