Topical Steroids & Bacterial Decolonization for Radiation Dermatitis

Topical Corticosteroid and Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment

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.

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.

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

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

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)

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)

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)

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)

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)

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)

Assessed through laboratory analysis of changes in microbial skin cultures and tape-strip gene expression analysis on skin samples before and after RT treatment

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)