NCT04865731CompletedPhase 2
A Phase II Clinical Trial of Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer Patients (CTMS# 20-0147)
The University of Texas Health Science Center at San Antonio1 site in 1 country6 target enrollmentStarted: June 15, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dermaprazole
Experimental
30 HNC patients who will be using Dermaprazole twice daily for 7 weeks
Intervention: Dermaprazole (Drug)
Aquaphor
Active Comparator
15 HNC patients using Aquaphor, the current clinical standard of care
Intervention: Aquaphor (Drug)
Outcomes
Primary Outcomes
Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher
Time Frame: 15 months
Number of radiation dermatitis adverse events defined by the NCI CTCAE version 5 that are graded as 2 or higher
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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