drugset / Trial / NCT03883828

Bacterial Decolonization to Prevent Radiation Dermatitis

NCT03883828

Phase 2/3 Completed 80 enrolled Montefiore Medical Center
RandomizedParallel-groupOpen-labelPrevention

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine Small molecule Topical
Subject Mupirocin Small molecule Intranasal

Indications