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Study planned but never formally submitted to the IRB
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bacterial decolonization | Experimental | Validated decolonization regimen |
|
| Topical corticosteroid | Experimental | Mometasone furoate 0.1% cream |
|
| Combination | Experimental | Validated decolonization regimen and mometasone furoate 0.1% cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacterial decolonization | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | Two weeks after RT treatment completed |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At study screening/enrollment, before RT treatment has started |
| Quality of life Score Change |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the cutaneous microbiome and transcriptome | Assessed through laboratory analysis of changes in microbial skin cultures and tape-strip gene expression analysis on skin samples before and after RT treatment | through study completion, an average of 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yana Kost | Montefiore Medical Center | Study Director |
| Lindsay Pattison | Montefiore Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center-Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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.
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|
| Mometasone furoate 0.1% cream | Drug | 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 |
|
| Bacterial decolonization and Mometasone furoate 0.1% cream | Drug | 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 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) |
| 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) | Two weeks after RT treatment completed |
| D014947 |
| Wounds and Injuries |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |