Clinical trial NCT02249884: Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis
Official title: Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiodermatitis
Keywords: radiodermatitis
head and neck neoplasms
Breast Neoplasms
Urea
Matricaria
chamomilla
chamomile
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2014-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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.

Eligibility criteria: Inclusion Criteria:

* Being an adult, over the age of 18 years old
* Owning diagnosis of breast or head and neck cancer
* Being first referred to the radiotherapy protocol
* Have absence of radiodermatitis and integrates skin to start radiotherapy
* Not have presented anticipated reaction of hypersensitivity to chamomile or any plant of the family Asteraceae or Compositae or urea.
* Demonstrate conditions to continue the intervention in their home environment when needed.

Exclusion Criteria:

* Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.

Primary outcomes:
measure: Time of occurrence of Radiodermatitis
timeFrame: 3 weeks
Secondary outcomes:
measure: Indicators of toxicity
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University Hospital of Brasília
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Paula Elaine D Reis, RN PhD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Marcia A Ciol, PhD
role: STUDY_DIRECTOR
References: