Bacterial Decolonization for the Prevention of Radiation Dermatitis in Patients with Breast or Head and Neck Cancer Receiving Radiotherapy
- Age >= 18
- Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated RT (>= 15 fractions) with curative intent, including post-operative patients deemed eligible for RT by their surgeons and radiation oncologists
- Prior RT to the region of interest
- Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds)
- Known allergy to chlorhexidine or mupirocin
I. To determine if bacterial decolonization prior to radiotherapy (RT) prevents development of high grade radiation dermatitis (RD) (grade 2-5).
I. To assess if the intervention improves quality of life compared to the control arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Prior to start of radiation therapy, patients receive mupirocin ointment intranasally twice daily (BID) and use chlorhexidine gluconate body wash once daily (QD) for 5 days and at weeks 2, 4, 6, and 8 of radiation therapy in the absence of unacceptable toxicity.
ARM II: Patients receive standard of care.
Trial Phase Phase II/III
Trial Type Prevention
Montefiore Medical Center-Weiler Hospital
- Primary ID 2018-9722
- Secondary IDs NCI-2021-02745
- Clinicaltrials.gov ID NCT03883828