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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
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
Montefiore Medical Center-Albert Einstein College of Medicine
The Bronx, New York, United States
Incidence of grade >2 RD
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)
Time frame: At study screening/enrollment, before RT treatment has started
Incidence of grade >2 RD
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)
Time frame: At last RT treatment session, an average of 5 weeks after treatment initiation
Incidence of grade >2 RD
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)
Time frame: Two weeks after RT treatment completed
Quality of life Score Change
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)
Time frame: At study screening/enrollment, before RT treatment has started
Quality of life Score Change
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)
Time frame: At last RT treatment session, an average of 5 weeks after treatment initiation
Quality of life Score Change
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)
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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
Time frame: Two weeks after RT treatment completed