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Dermaprazole Cream for Radiation Dermatitis in Definitive Head and Neck Cancer

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT04865731
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
75.5
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase II Clinical Trials of Dermaprazole Cream for Radiation Dermatitis in Definitive Head and Neck Cancer Patients (CTMS# 20-0147)
Actual Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Sep 30, 2027
Anticipated Study Completion Date :
Sep 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dermaprazole

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

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.
Other Names:
  • esomeprazole

    		•
    Active Comparator: Aquaphor

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

    Drug: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Rates of clinically significant radiation dermatitis as defined as NCI CTCAE version 5 grade 2 or higher [15 months]

      Number of adverse events defined by the NCI CTCAE rated 3 or higher

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mays Cancer Center San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio

    Investigators

    • Principal Investigator: Mohamad A Fakhreddine, MD, The University of Texas Health Science Center - Mays Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT04865731
    Other Study ID Numbers:
    • CTMS# 20-0147
    • HSC20210301H
    First Posted:
    Apr 29, 2021
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Dermatitis
    Radiodermatitis
    Esomeprazole

    Study Results

    No Results Posted as of Jun 21, 2022