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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02249884
Other study ID # DRCradiodermatitis
Secondary ID
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


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
See also
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Enrolling by invitation NCT02289365 - Orally Administrated JBM-TC4 Prevents Acute Radiodermatitis in Breast Cancer Patients Phase 2
Completed NCT04483856 - Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis. N/A
Completed NCT02922244 - Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients N/A
Recruiting NCT05886673 - Development of a Protective Cream Against Radiodermatitis Caused by Radiotherapy. N/A
Withdrawn NCT01544504 - Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy Phase 1/Phase 2
Completed NCT03255980 - Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid® N/A
Not yet recruiting NCT03557983 - Evaluation of Fenofibrate on Radiation-induced Skin Injury N/A
Completed NCT02247830 - Management Radiodermatitis in Patients With Breast or Head and Neck Cancer Phase 3
Terminated NCT01367990 - Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy Phase 1
Completed NCT03924011 - Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy N/A
Terminated NCT01263366 - Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients Phase 1
Not yet recruiting NCT04617730 - Efficacy of the Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold. Phase 1/Phase 2
Not yet recruiting NCT05535452 - Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy N/A
Completed NCT04239560 - Preventive Effect of Boron-based Gel on Radiation Dermatitis Phase 3
Withdrawn NCT04692389 - Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis. N/A
Enrolling by invitation NCT04067310 - Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis. N/A
Enrolling by invitation NCT02251392 - Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis Phase 3