Radiation Dermatitis
Conditions
Brief summary
The purpose of this study is to determine whether bacterial decolonization of the nares and skin, topical steroid therapy, or a combination of the two regimens prior to treatment with radiotherapy (RT) for breast and head and neck cancer patients can prevent grade 2 or higher grade radiation dermatitis (RD) graded via the Common Terminology Criteria for Adverse Events (CTCAE) scale and improve quality of life.
Interventions
DRUGBacterial decolonization
Validated decolonization regimen consisting of intranasal 2% mupirocin ointment applied twice daily as well as chlorhexidine wash used daily to the body. This regimen is conducted by the patient for 5 consecutive days prior to the start of RT and is repeated for an additional five days every other week continuing until either the development of moist desquamation or 2 weeks after the completion of RT.
Mometasone furoate 0.1% cream to be applied twice a day to the irradiated area, starting on the first day of RT and continuing until either the development of moist desquamation or 2 weeks after the completion of RT
DRUGBacterial decolonization and Mometasone furoate 0.1% cream
Validated decolonization regimen consisting of intranasal 2% mupirocin ointment applied twice daily as well as chlorhexidine wash used daily to the body. This regimen is conducted by the patient for 5 consecutive days prior to the start of RT and is repeated for an additional five days every other week continuing until either the development of moist desquamation or 2 weeks after the completion of RT. Also, mometasone furoate 0.1% cream will be applied twice a day to the irradiated area, starting on the first day of RT and continuing until either the development of moist desquamation or 2 weeks after the completion of RT
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Prior to recruitment, the study statistician conducted randomization in a 1:1:1 model, which will divide patients into three arms: (a) bacterial decolonization regimen (b) topical corticosteroid use daily or (c) topical corticosteroid use daily with antibacterial decolonization regimen.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 * Diagnosis of a breast or head and neck cancer with plans for fractionated RT (greater than or equal to 15 fractions in 40 Gy (Gray)) with curative intent, including post-operative patients deemed eligible for RT by their surgeons and radiation oncologists
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 intervention therapies)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade >2 RD | At study screening/enrollment, before RT treatment has started | Assessed via the CTCAE scale before and after RT treatment via clinical photographs graded by a blinded dermatologist (minimum grade 0, maximum grade 5, higher score is worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life Score Change | At study screening/enrollment, before RT treatment has started | Assessed by the Skindex-16 survey given to the patient before and after RT treatment (minimum score 0, maximum score 96, higher score is worse outcome) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in the cutaneous microbiome and transcriptome | through study completion, an average of 2 years | Assessed through laboratory analysis of changes in microbial skin cultures and tape-strip gene expression analysis on skin samples before and after RT treatment |
Countries
United States
Outcome results
None listed