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.
Brief Title
Bacterial Decolonization to Prevent Radiation Dermatitis
Categories
Completion Date
Completion Date Type
Actual
Conditions
Radiation Dermatitis
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03883828
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9722
Overall Status
Completed
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment
Primary Outcomes
Outcome Description
The number of high-grade radiation dermatitis events (grade 2-5) were assessed at the end of treatment. Instances of Grade 2-5 radiation dermatitis was assessed using photographs taken during the final radiation therapy visit. A blinded dermatologist viewed the images and assessed for toxicity grading using CTCAE Version 5.0 criteria.
Outcome Measure
Number of Participants With Incidence of High Grade Radiation Dermatitis
Outcome Time Frame
Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeks
Outcome Description
Change in quality of life from the beginning to the end of radiation therapy was used to assess if patients receiving decolonization experienced less impact on quality of life compared to standard of care radiation therapy treatment based on the Skindex-16 survey. The Skindex-16 is a validated 16-item self-administered survey instrument that measures the effects of skin disease on patients' quality of life. Scores were determined based on changes from baseline in the three scale subcategories: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30) where 0 = never bothered and 6 = always bothered. Net positive changes in respective subscale scoring were correlated with an improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring corresponded to a decrease in that particular Quality of life assessment.
Outcome Measure
Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey
Outcome Time Frame
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
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Beth Mclellan
Investigator Email
bmclella@montefiore.org
Investigator Phone
718-862-8840