Phase 3
N=80
Bacterial Decolonization to Prevent Radiation Dermatitis
Radiation Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03883828 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants With Incidence of High Grade Radiation Dermatitis — 0; 9 Participants — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chlorhexidine gluconate solution (Drug); Mupirocin Ointment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Incidence of High Grade Radiation Dermatitis |
0; 9 | 0.004 sig |
| PRIMARY Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey |
3; 4; 5; 0; 0; 0 | 0.20 |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18
- Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated radiation therapy (≥ 15 fractions) with curative intent
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03883828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.