Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865731
• Other study ID #: CTMS# 20-0147
• Secondary ID: HSC20210301H
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2022
• Est. completion date: September 30, 2028

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Epp Goodwin
• Phone: 210-450-5798
• Email: goodwine[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 cancer (HNC) patients.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Dermatitis
• Head and Neck Neoplasms
• Radiodermatitis

Intervention

Drug:
• Dermaprazole
Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.
• Aquaphor
Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.

Locations

Country	Name	City	State
United States	Mays Cancer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

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