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Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

Primary Purpose

Cancer of the Head and Neck

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dermaprazole

Aquaphor

About this trial

This is an interventional treatment trial for Cancer of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mays Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dermaprazole

Aquaphor

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04865731

First Posted

April 28, 2021

Last Updated

June 23, 2023

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT04865731

Brief Title

Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

Official Title

A Phase II Clinical Trial of Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer Patients (CTMS# 20-0147)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

September 30, 2027 (Anticipated)

Study Completion Date

September 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the Head and Neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dermaprazole

Arm Type

Experimental

Arm Description

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

Arm Title

Aquaphor

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dermaprazole

Other Intervention Name(s)

esomeprazole

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Aquaphor

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rates of clinically significant radiation dermatitis as defined as NCI CTCAE version 5 grade 2 or higher

Description

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

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Epp Goodwin

Phone

210-450-5798

goodwine@uthscsa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy Wagner, MD

Organizational Affiliation

The University of Texas Health Science Center - Mays Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mays Cancer Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Wagner, MD

Phone

210-450-6496

wagnert@uthscsa.edu

First Name & Middle Initial & Last Name & Degree

Carol Jenkins, RN

Phone

210-450-5924

jenkinsca@uthscsa.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

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