Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis (DRCPTR)

University of Brasilia

Status and phase: Completed; Phase 2

Conditions: Radiodermatitis

Treatments: Drug: Chamomile Dose A; Drug: Chamomile Dose C; Drug: Chamomile Dose B; Drug: Urea Dose B; Drug: Urea Dose C; Drug: Urea Dose A

Study type: Interventional

Funder types: Other

Identifiers

NCT02249884

DRCradiodermatitis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 6 patient groups

Urea Dose A

Experimental group

Description:

Topical application of the urea cream in concentration A. The product should be applied on the skin three times daily over 3 weeks.

Treatment:

Drug: Urea Dose A

Urea Dose B

Experimental group

Description:

Topical application of the urea cream in concentration B. The product should be applied on the skin three times daily over 3 weeks.

Treatment:

Drug: Urea Dose B

Urea Dose C

Experimental group

Description:

Topical application of the urea cream in concentration C. The product should be applied on the skin three times daily over 3 weeks.

Treatment:

Drug: Urea Dose C

Chamomile Dose A

Experimental group

Description:

Topical application of chamomile recutita gel in concentration A. The product should be applied on the skin three times daily over 3 weeks.

Treatment:

Drug: Chamomile Dose A

Chamomile Dose B

Experimental group

Description:

Topical application of chamomile recutita gel in concentration B. The product should be applied on the skin three times daily over 3 weeks.

Treatment:

Drug: Chamomile Dose B

Chamomile Dose C

Experimental group

Description:

Topical application of chamomile recutita gel in concentration C. The product should be applied on the skin three times daily over 3 weeks.

Treatment:

Drug: Chamomile Dose C