Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
- Conditions
- Cancer of the Head and Neck
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria:<br><br> - Patients with head and neck malignancy (including radiation therapy to primary head<br> cancers of any histology and/or neck lymphatics, excluding brain malignancies)<br><br> - Biopsy proven diagnosis of head and neck malignancy<br><br> - Planned to receive definitive chemoradiation of at least 66Gy<br><br> - Age 18 years or older<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2<br><br> - Written Informed Consent<br><br> - History and Physical within 12 weeks of enrollment<br><br>Exclusion Criteria:<br><br> - Prior head and neck radiotherapy<br><br> - Neoadjuvant chemotherapy<br><br> - Any serious medical condition or illness that would preclude the safe administration<br> of the trial treatment including, but not limited to, active infection, symptomatic<br> heart failure, unstable angina, psychiatric illness or social situations that would<br> limit compliance with treatment<br><br> - Currently taking proton pump inhibitors. Eligible if discontinues with physician<br> approval.<br><br> - Lack of concurrent chemotherapy<br><br> - Open wound at time of simulation<br><br> - Known autoimmune, connective tissue, or skin disorder; or other theoretical<br> radiosensitivity to include bullous pemphigoid, dermatomyositis, lupus of the skin<br> and scleroderma
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rates of clinically significant radiation dermatitis as defined as NCI CTCAE version 5 grade 2 or higher
- Secondary Outcome Measures
Name Time Method