drugset / Trial / NCT05269160
Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)
Non-randomizedSequentialOpen-labelSupportive care
Summary
Radiotherapy is a mainstay of treatment in breast cancer treatment, in the adjuvant setting. Radiation dermatitis occurs in up to 65% of these patients; currently, there is no standard of care for this treatment-related toxicity. The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream (termed "Dermaprazole") in patients who require radiation for breast cancer in the adjuvant setting.
Timeline
- Start
- 2023-04-24
- Primary completion
- 2023-06-26
- Completion
- 2024-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esomeprazole | Small molecule | 1 % | Topical |
| Subject | Esomeprazole | Small molecule | 2 % | Topical |