Clinical Trial: Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study

Brief Summary: 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.

Detailed Summary: The study is being conducted in Center for High Complexity Oncology (CACON) located at the University Hospital of Brasília (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.
Sponsor: University of Brasilia

Current Primary Outcome: Time of occurrence of Radiodermatitis [ Time Frame: 3 weeks ]

Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).


Original Primary Outcome: Same as current

Current Secondary Outcome: Indicators of toxicity [ Time Frame: 3 weeks ]

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.



Original Secondary Outcome: Same as current

Information By: University of Brasilia

Dates:
Date Received: September 20, 2014
Date Started: February 2014
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015