This phase II trial determines the side effect and efficacy of dermaprazole in treating radiation dermatitis in patients with head and neck cancer. Cancer patients who are receiving radiation therapy may experience dermatitis, and there is no gold standard treatment for it. This trial aims to see whether a kind of skin ointment, called dermaprazole may help to treat radiation dermatitis.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04865731.
PRIMARY OBJECTIVE:
I. Determine if objectively lower rates of significant radiation dermatitis occur with esomeprazole magnesium (dermaprazole) for head and neck cancer (HNC) patients receiving definitive radiation when compared to patients receiving petrolatum-mineral oil-lanolin-ceresin ointment (Aquaphor).
SECONDARY OBJECTIVES:
I. To assess the highest grade of Common Terminology Criteria for Adverse Events (CTCAE) version 5 radiation dermatitis during radiation treatment.
II. To assess the time to occurrence of CTCAE version 5 grade 2 or higher acute radiation dermatitis.
III. To assess the time to healing if CTCAE version 5 grade 2 or higher acute radiation dermatitis develops.
IV. To evaluate quality of life via acute and long-term symptoms and symptom scores utilizing the SkinDex16 scoring system.
V. To evaluate the threshold dose at which radiation dermatitis (RD) appears in either arm, utilizing skin dose tracking structures (V20 to V80 in 5 Gy increments reaching skin shell contours of “skin minus 3 millimeters” and “skin minus 5 millimeters”).
VI. To evaluate the threshold dose at which RD appears in either arm, using the same metrics as in Objective V, but with a new simulation scan in the last week of radiotherapy.
VII. To evaluate the effect of dermaprazole on inflammatory markers: CRP, TNFa, IL-1b, IL-6, by measuring values before, during, and after treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply dermaprazole topically twice daily (BID) along the area exposed to radiation from the day of simulation (1 week prior to the start of radiation) to 2 weeks after radiation completion. Patients receive standard of care intensity-modulated radiation therapy (RT) 5 days per week for 7 weeks. Patients also undergo computed tomography (CT) simulation on study and blood sample collection at baseline and on study.
ARM II: Patients apply Aquaphor topically BID along the area exposed to radiation from the day of simulation (1 week prior to the start of radiation) to 2 weeks after radiation completion. Patients receive standard of care intensity-modulated RT 5 days per week for 7 weeks. Patients also undergo CT simulation on study and blood sample collection at baseline and on study.
After completion of study treatment, patients are followed up at 30 and 90 days, 6, 9, 12, 18, 24, 36, 48, and 60 months.
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
Principal InvestigatorShraddha Mahesh Dalwadi
