Cancer of the Head and Neck Clinical Trial
Official title:
A Phase II Clinical Trial of Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer Patients (CTMS# 20-0147)
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | September 30, 2028 |
Est. primary completion date | September 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mays Cancer Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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