Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the prevention of radiodermatitis in patients with breast cancer or head and neck cancer undergoing radiotherapy.
Prophylactic Trial will consist of a control group and two experimental groups, namely control group (usual care), Experimental Group 01 (usual care + topical application of the gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based cream).
The doses used in the different compounds are being in test since february 2014 by a dose-response curve study, using 6 groups with three doses of urea cream and three doses of C. recutita gel.
The study will be conducted at the Center for High Complexity Oncology at University Hospital of BrasÃlia (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according to established criteria to classify the effects of radiotherapy, which identifies grades 0, 1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
It is considered that patients undergoing radiotherapy in use gel based on C. recutita or use of cream based urea three times a day, concomitant radiotherapy, would present the following hypotheses:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Chamomilla recutita gel | Experimental | Experimental Group 01: usual care + topical application of the gel recutita chamomile. Such intervention will be characterized by topical application of the gel C. recutita, concomitantly to the initiation of radiotherapy, should be applied on the irradiated three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care). |
|
| 2 Urea cream | Experimental | Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the area irradiated three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care). |
|
| Control Group (Usual Care) | No Intervention | The usual care consists of nursing consultation with instructional material (Manual guidelines) that is already done systematically in service. This query is made with all patients starting radiotherapy. Here, guidelines are provided about skin care and hydration, using topical moisturizing soap solution over the bath. Such information is contained in the manual that is provided to the patient during the consultation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chamomilla recutita gel | Other | Such intervention will be characterized by topical application of C. recutita gel, concomitantly to the initiation of radiotherapy, should be applied on the irradiated region three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of radiodermatitis | Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy). | 5 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elaine Barros Ferreira, RN | University of Brasilia | Principal Investigator |
| Paula Elaine Diniz dos 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 | Brazil |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Urea cream | Drug | Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the irradiated region three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care). |
|
|
| D014947 |
| Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |