NCT02249884

Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Radiodermatitis

Interventions

Type	Name	Description
DRUG	Urea Dose A	Urea cream for topical use.
DRUG	Urea Dose B	Urea cream for topical use.
DRUG	Urea Dose C	Urea cream for topical use.
DRUG	Chamomile Dose A	Chamomile gel for topical use.
DRUG	Chamomile Dose B	Chamomile gel for topical use.
DRUG	Chamomile Dose C	Chamomile gel for topical use.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-03-01
• Completion: 2015-11-01
• First posted: 2014-09-26
• Last updated: 2015-12-02

Locations

1 site across 1 country: Brazil