Pantoprazole in Cisplatin Nephrotoxicity

Sherief Abd-Elsalam

Status and phase: Enrolling; Phase 3

Conditions: Oncology

Treatments: Drug: Pantoprazole high dose; Drug: Cisplatin; Drug: Pantoprazole low dose; Other: Standard hydration

Study type: Interventional

Funder types: Other

Identifiers

NCT04217512

eman ghoneim

Details and patient eligibility

About

Pantoprazole in Cisplatin Nephrotoxicity

Full description

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

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with head and neck cancer

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Standard hydration alone

Active Comparator group

Description:

Cisplatin with standard hydration

Treatment:

Other: Standard hydration

Drug: Cisplatin

Pantoprazole high dose

Active Comparator group

Description:

Cisplatin with standard hydration with pantoprazole 1.6 mg/kg

Treatment:

Other: Standard hydration

Drug: Pantoprazole high dose

Drug: Cisplatin

Pantoprazole Low dose

Active Comparator group

Description:

Cisplatin with standard hydration with pantoprazole 0.6 mg/kg

Treatment:

Other: Standard hydration

Drug: Pantoprazole low dose

Drug: Cisplatin