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Mupirocin Ointment for Radiation Burn

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

No Placebo-Only Group

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 Burn

Timeline

Screening ~ 3 weeks3 visits

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

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

Itch

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Arm

Control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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