Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Mays Cancer Center
San Antonio, Texas 78229
Contact:
Mohamad Fakhreddine, MD
210-450-5652
fakhreddine@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Epp Goodwin
210-450-5798
goodwine@uthscsa.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.