Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Clinical Trial of Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer Patients (CTMS# 20-0147)

Conditions
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Cancer of the Head and Neck

Intervention / Treatment
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* Drug: Dermaprazole
* Drug: Aquaphor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermaprazole<br>30 HNC patients who will be using Dermaprazole twice daily for 7 weeks | Drug: Dermaprazole<br>* Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.<br>* Other names: esomeprazole;|
| Active Comparator: Aquaphor<br>15 HNC patients using Aquaphor, the current clinical standard of care | Drug: Aquaphor<br>* Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of clinically significant radiation dermatitis as defined as NCI CTCAE version 5 grade 2 or higher | Number of adverse events defined by the NCI CTCAE rated 3 or higher | 15 months |