Bacterial Decolonization to Prevent Radiation Dermatitis
Summary
The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.
Timeline
- Start
- 2019-06-03
- Primary completion
- 2021-12-02
- Completion
- 2021-12-02
Outcome
Mixed primary results
registry COUNT_OF_PARTICIPANTS Treatment Arm: 0 Participants COUNT_OF_PARTICIPANTS Control: 9 Participants analysis (superiority test); Treatment Arm vs Control; p = 0.004 NCT03883828 ↗
registry analysis (superiority test); Treatment Arm vs Control; p = 0.20 NCT03883828 ↗
registry analysis (superiority test); Treatment Arm vs Control; p = 0.05 NCT03883828 ↗
registry analysis (superiority test); Treatment Arm vs Control; p = 0.73 NCT03883828 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chlorhexidine | Small molecule | — | Topical |
| Subject | Mupirocin | Small molecule | — | Intranasal |