Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

Phase 2

Active, not recruiting

• Conditions: Cancer of the Head and Neck
• Interventions: Drug: Dermaprazole; Drug: Aquaphor

• Registration Number: NCT04865731
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

In this study, the study team seek to conduct a pilot clinical study to evaluate the safety and efficacy of a reformulated proton pump inhibitor (PPI) cream (Dermaprazole) in definitive head and neck cancer (HNC) patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Study Start: 2022-06-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Patients with head and neck malignancy (including radiation therapy to primary head cancers of any histology and/or neck lymphatics, excluding brain malignancies)
• Biopsy proven diagnosis of head and neck malignancy
• Planned to receive definitive chemoradiation of at least 66Gy
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• Written Informed Consent
• History and Physical within 12 weeks of enrollment

Exclusion Criteria

• Prior head and neck radiotherapy
• Neoadjuvant chemotherapy
• Any serious medical condition or illness that would preclude the safe administration of the trial treatment including, but not limited to, active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment
• Currently taking proton pump inhibitors. Eligible if discontinues with physician approval.
• Lack of concurrent chemotherapy
• Open wound at time of simulation
• Known autoimmune, connective tissue, or skin disorder; or other theoretical radiosensitivity to include bullous pemphigoid, dermatomyositis, lupus of the skin and scleroderma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermaprazole	Dermaprazole	30 HNC patients who will be using Dermaprazole twice daily for 7 weeks
Aquaphor	Aquaphor	15 HNC patients using Aquaphor, the current clinical standard of care

Primary Outcome Measures

Name	Time	Method
Rates of clinically significant radiation dermatitis as defined as NCI CTCAE version 5 grade 2 or higher	15 months	Number of adverse events defined by the NCI CTCAE rated 3 or higher

Trial Locations

Locations (1)

Mays Cancer Center; 🇺🇸 San Antonio, Texas, United States