Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Cancer of the Head and Neck

Treatments: Drug: Dermaprazole; Drug: Aquaphor

Study type: Interventional

Funder types: Other

Identifiers

NCT04865731

CTMS# 20-0147

HSC20210301H (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Dermaprazole

Experimental group

Description:

30 HNC patients who will be using Dermaprazole twice daily for 7 weeks

Treatment:

Drug: Dermaprazole

Aquaphor

Active Comparator group

Description:

15 HNC patients using Aquaphor, the current clinical standard of care

Treatment:

Drug: Aquaphor