This phase I/II trial tests the safety, side effects, best dose, and effectiveness of Dermaprazole for managing radiation dermatitis in patients with head and neck and breast cancer undergoing radiation therapy. Radiation therapy is used to treat many types of cancer, including head and neck and breast cancer. One of the side effects of radiation is radiation dermatitis, or inflammation of the skin due to radiation. It is very difficult to treat radiation dermatitis, which can lead to painful blistering and sometimes even infection. Currently, there is no proven treatment for this side effect. Dermaprazole is made out of a popular and safe over the counter antiacid medication (esomeprazole) that has been shown to have anti-inflammatory as well as anti-oxidant and anti-fibrotic effects that may help manage radiation dermatitis in head and neck and breast cancer patients undergoing radiation therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT05269160.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To define the safety and maximum feasible dose (MFD) of esomeprazole topical cream (Dermaprazole) in preventing radiation dermatitis for head & neck, and breast cancer patients. This will be evaluated by application of the cream: (Phase I-Safety)
Ia. Prior to, during and after radiation via patch testing to assess for baseline irritant or contact dermatitis;
Ib. Prior to, during and after radiation via monitoring treatment field receiving prophylactic Dermaprazole to assess for adverse events.
II. To evaluate clinically bothersome radiation dermatitis rate for head & neck, and breast cancer patients at maximum feasible dose. (Phase II-Efficacy)
SECONDARY OBJECTIVES:
I. To assess the rate of grade 2 or higher acute radiation dermatitis.
II. To assess time to occurrence of grade 2 or higher acute radiation dermatitis.
III. To assess the time to healing if grade 2 or higher acute radiation dermatitis develops.
IV. To assess patient-reported quality of life outcomes using SkinDex16.
V. To assess radiation compliance; defined as the number of missed radiation treatments due to skin toxicity.
OUTLINE: This is a dose-escalation study of Dermaprazole. Patients are assigned to 1 of 2 arms.
ARM A (HEAD AND NECK): Patients undergo standard of care radiation therapy 5 days a week for 6-7 weeks. Patients apply Dermaprazole topically twice daily (BID) from the day of computed tomography (CT) simulation up to 2 weeks after completion of radiation in the absence of disease progression or unacceptable toxicity.
ARM B (BREAST): Patients undergo standard of care radiation therapy 5 days a week for 3-7 weeks. Patients apply Dermaprazole topically BID from the day of CT simulation up to 2 weeks after completion of radiation in the absence of disease progression or unacceptable toxicity.
After completion of radiation treatment, patients are followed up at 1 month and 6 months.
Trial PhasePhase I/II
Trial Typesupportive care
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorMichelle Suzanne Ludwig
