Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
Purpose
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.
Condition
- Cancer of the Head and Neck
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Dermaprazole |
30 HNC patients who will be using Dermaprazole twice daily for 7 weeks |
|
Active Comparator Aquaphor |
15 HNC patients using Aquaphor, the current clinical standard of care |
|
Recruiting Locations
Mays Cancer Center
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio