Radiodermatitis Clinical Trial
Official title:
Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial
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 Brasília (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:
- Null: equal incidence and severity of radiodermatitis when compared to the control group
(usual care);
- Alternative 1: low incidence and severity of radiodermatitis when compared to patients
who comprised the control group (usual care).
- Alternative 2: lower incidence and severity of radiodermatitis between the experimental
groups (urea and chamomile).
;
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