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| Name | Class |
|---|---|
| Avario Healthcare Inc. | INDUSTRY |
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The purpose of this study is to determine whether NeoVIDERM is effective at preventing radiation dermatitis in patients receiving external beam radiation therapy to the head and neck or breast areas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm B: standard of care plus NeoVIDERM cream | Experimental | Patients will apply NeoVIDERM cream to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. Patients will also perform standard of care skin treatment. |
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| Arm A: standard skin care | Active Comparator | Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatments. If they develop dry desquamation, they will be asked to apply Flamazine twice a day until dermatitis resolves. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aveeno cream | Other | Twice a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum skin toxicity | The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of neoVIDERM compared to patients treated with institutional standard skin care. | 7 weeks post beginning of radiation treatments |
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Inclusion criteria: For patients receiving radiation to the breast
Inclusion criteria: For patients receiving radiation to the head and neck
Exclusion criteria: For patients receiving radiation to the breast or the head and neck
Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it).
The Fitzpatrick Scale:
Rarely burns, tans with ease
Allergic to any ingredient in Neoviderm cream
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| Name | Affiliation | Role |
|---|---|---|
| Te Vuong, MD | Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Flamazine cream | Other | Twice a day, when there is dry desquamation |
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| NeoVIDERM cream | Other | Three times a day |
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| D017437 |
| Skin and Connective Tissue Diseases |