MedTrace Logo

Bacterial Decolonization to Prevent Radiation Dermatitis

NCT03883828 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Radiation Dermatitis

Interventions

DRUG

Chlorhexidine gluconate solution

Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.

DRUG

Mupirocin Ointment

Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Beth McLellan, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2021-12-02
Completion
2021-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883828 on ClinicalTrials.gov