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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04865731
Other study ID # CTMS# 20-0147
Secondary ID HSC20210301H
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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