Status:
COMPLETED
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Cancer of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04865731
Start Date
June 15 2022
End Date
June 18 2024
Last Update
August 6 2025
Active Locations (1)
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1
Mays Cancer Center
San Antonio, Texas, United States, 78229