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Mupirocin Ointment for Radiation Skin Damage

Phase 2 & 3
Waitlist Available
Led By Beth McLellan, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first week (week 1) to the last week of treatment (study week depends on patient's length of treatment), approximately 5 to 8 weeks
Awards & highlights

Summary

This trial tests if using an antibiotic ointment in the nose and an antiseptic wash on the skin before radiotherapy can prevent severe skin reactions in patients with head, neck, or breast cancer. This approach is based on findings that bacteria in the nose can increase the risk of these reactions. The goal is to improve patients' quality of life during treatment.

Eligible Conditions
  • Radiation Skin Damage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first week (week 1) to the last week of treatment (study week depends on patient's length of treatment), approximately 5 to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first week (week 1) to the last week of treatment (study week depends on patient's length of treatment), approximately 5 to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey
Number of Participants With Incidence of High Grade Radiation Dermatitis

Side effects data

From 2021 Phase 2 & 3 trial • 80 Patients • NCT03883828
3%
Itch
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Arm
Control

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment2 Interventions
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.
Group II: ControlActive Control1 Intervention
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mupirocin Ointment
2019
Completed Phase 3
~80
Chlorhexidine gluconate solution
2019
Completed Phase 3
~160

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
455 Previous Clinical Trials
582,987 Total Patients Enrolled
Beth McLellan, MD5.01 ReviewsPrincipal Investigator - Montefiore Medical Center
Montefiore Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled
~13 spots leftby Sep 2025
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