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| Name | Class |
|---|---|
| University of Washington | OTHER |
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Dose response curve to define the security and tolerable dose to be used for prevention and treatment of radiodermatitis in patients with breast or head and neck cancer.
The study is being conducted in Center for High Complexity Oncology (CACON) located at the University Hospital of BrasÃlia (HUB). Has as its target population subjects diagnosed with breast and head and neck cancer undergoing radiotherapy. Three doses of urea cream are being tested. Participants are subjected to simple randomization technique, in which the members of the study are directly allocated in groups set forth, without any intermediate step. Patients are identified, go to a nursing consultation for general orientations about treatment. After the consultation, patients are invited to participate in the study. The patient should express its acceptance through the informed consent form. Data are being collected through interviews and medical records. Patients are being evaluated during three weeks, considering the toxicity of the intervention and the beginning of radiodermatitis. To evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS). For reliable assessment and record of the evolution throughout the treatment and study, patients will be photographed weekly (D0, D5, D10, D15). Will be photographed major regions subject to evaluation: frontal, right side profile and left side profile with Photographic camera Nikon P510. The data will be inserted into Statistical Package for Social Sciences (SPSS), version 18.0, for the analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urea Dose A | Experimental | Topical application of the urea cream in concentration A. The product should be applied on the skin three times daily over 3 weeks. |
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| Urea Dose B | Experimental | Topical application of the urea cream in concentration B. The product should be applied on the skin three times daily over 3 weeks. |
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| Urea Dose C | Experimental | Topical application of the urea cream in concentration C. The product should be applied on the skin three times daily over 3 weeks. |
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| Chamomile Dose A | Experimental | Topical application of chamomile recutita gel in concentration A. The product should be applied on the skin three times daily over 3 weeks. |
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| Chamomile Dose B | Experimental | Topical application of chamomile recutita gel in concentration B. The product should be applied on the skin three times daily over 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urea Dose A | Drug | Urea cream for topical use. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time of occurrence of Radiodermatitis | Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG). | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Indicators of toxicity | Evaluate the tolerance and safety of the intervention according to the assessment of toxicity during the intervention. To evaluate the toxicity will be considered signs and symptoms referable to the region of application of the product, such as skin rash, urticaria, vesicles, blisters, pustules, as well as the patient's report of discomfort, burning, stinging and itching. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Elaine D Reis, RN PhD | University of Brasilia | Study Director |
| Marcia A Ciol, PhD | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of BrasÃlia | BrasÃlia | Federal District | Brazil |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| D006258 | Head and Neck Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| Chamomile Dose C | Experimental | Topical application of chamomile recutita gel in concentration C. The product should be applied on the skin three times daily over 3 weeks. |
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| Urea Dose B | Drug | Urea cream for topical use. |
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| Urea Dose C | Drug | Urea cream for topical use. |
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| Chamomile Dose A | Drug | Chamomile gel for topical use. |
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| Chamomile Dose B | Drug | Chamomile gel for topical use. |
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| Chamomile Dose C | Drug | Chamomile gel for topical use. |
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| 3 weeks |
| D014947 |
| Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |