Phase 3
Completed N=80
Bacterial Decolonization to Prevent Radiation Dermatitis
Source: ClinicalTrials.gov NCT03883828 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Number of Participants With Incidence of High Grade Radiation Dermatitis — 0; 9 Participants — p=0.004
◆ Published Evidence
Established
37citations · ~12 / year
Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial.
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.
Linked Publications
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Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.