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| Name | Class |
|---|---|
| Avario Healthcare Inc. | INDUSTRY |
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The purpose of this study is to determine whether Alkagin paste is effective at preventing radiodermatitis in patients receiving external beam radiation therapy to the perineal area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: standard of 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 treatment |
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| Arm B: standard of care plus Alkagin paste | Experimental | Patients will apply Alkagin Paste to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. They will also perform standard of care skin treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aveeno cream | Other | Apply cream on irradiated area 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 Alkagin Paste compared to patients treated with institutional standard skin care. | 7 weeks post beginning of radiation treatments |
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Inclusion Criteria:
Exclusion Criteria:
The Fitzpatrick Scale:
Type I (scores 0-7) White; very fair; freckles. Always burns, never tans
Type II (scores 8-16) White; fair. Usually burns, tans with difficulty
Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans
Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease
Type V (scores over 30) Dark brown. Very rarely burns, tans very easily
Type VI Black. Never burns, tans very easily
2) Patients with an allergic reaction to Alkagin Paste
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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 |
|---|---|
| D001005 | Anus Neoplasms |
| D012004 | Rectal Neoplasms |
| D014565 | Urogenital Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Alkagin paste | Other | Apply Alkagin paste three times a day. |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |