Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis

Radiodermatitis Clinical Trial

— DRCPTR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249884
• Other study ID #: DRCradiodermatitis
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2014
• Last updated: November 30, 2015
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Radiodermatitis

Intervention

Drug:
• Urea Dose A
Urea cream for topical use.
• Urea Dose B
Urea cream for topical use.
• Urea Dose C
Urea cream for topical use.
• Chamomile Dose A
Chamomile gel for topical use.
• Chamomile Dose B
Chamomile gel for topical use.
• Chamomile Dose C
Chamomile gel for topical use.

Locations

Country	Name	City	State
Brazil	University Hospital of Brasília	Brasilia	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
University of Brasilia	University of Washington

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of occurrence of Radiodermatitis	Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).	3 weeks	No
Secondary	Indicators of toxicity	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.	3 weeks	Yes