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Bacterial Decolonization to Prevent Radiation Dermatitis

Primary Purpose

Radiation Dermatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate solution
Mupirocin Ointment
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiation Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Arm

Control

Arm Description

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.

Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.

Outcomes

Primary Outcome Measures

Incidence of high grade radiation dermatitis rated by CTCAE
1. The primary goal is to determine if bacterial decolonization is associated with less severe radiation dermatitis. The primary endpoint is the incidence of high-grade radiation dermatitis (grade 2-5) at the end of treatment. Radiation dermatitis grading will be assessed by photographs taken at the last radiation therapy visit, and a blinded dermatologist will view the images and assess for toxicity grading.
Quality of life rated by the Skindex
2. The secondary goal is to assess if the intervention prevents decrease in quality of life compared to the control arm. The secondary endpoint will measure the change in quality of life from the beginning to the end of radiation therapy, to assess if patients receiving decolonization experience less impact on quality of life compared to standard of care radiation therapy treatment. Quality of life will be measured by the Skindex-16, a validated 16-item self-administered survey instrument that measures the effects of skin disease on patients' quality of life. Scores vary from 0 (no effect) to 100 (effect experienced all the time), and responses are aggregated in symptoms (four items), emotions (seven items), and functioning scales (five items). Higher scores correlate with highest quality of life, while lower scores correspond to poorer quality of life.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2019
Last Updated
September 12, 2022
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03883828
Brief Title
Bacterial Decolonization to Prevent Radiation Dermatitis
Official Title
Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mupirocin Ointment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of high grade radiation dermatitis rated by CTCAE
Description
1. The primary goal is to determine if bacterial decolonization is associated with less severe radiation dermatitis. The primary endpoint is the incidence of high-grade radiation dermatitis (grade 2-5) at the end of treatment. Radiation dermatitis grading will be assessed by photographs taken at the last radiation therapy visit, and a blinded dermatologist will view the images and assess for toxicity grading.
Time Frame
Radiation dermatitis (graded by the CTCAE) will be assessed at the last treatment session (study week depends on patient's length of treatment, but ranges from 5 weeks to 8 weeks)
Title
Quality of life rated by the Skindex
Description
2. The secondary goal is to assess if the intervention prevents decrease in quality of life compared to the control arm. The secondary endpoint will measure the change in quality of life from the beginning to the end of radiation therapy, to assess if patients receiving decolonization experience less impact on quality of life compared to standard of care radiation therapy treatment. Quality of life will be measured by the Skindex-16, a validated 16-item self-administered survey instrument that measures the effects of skin disease on patients' quality of life. Scores vary from 0 (no effect) to 100 (effect experienced all the time), and responses are aggregated in symptoms (four items), emotions (seven items), and functioning scales (five items). Higher scores correlate with highest quality of life, while lower scores correspond to poorer quality of life.
Time Frame
Quality of life will be assessed at the first (week 1) and last week of treatment (study week depends on patient's length of treatment, but ranges from 5 weeks to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth McLellan, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bacterial Decolonization to Prevent Radiation Dermatitis

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