Radiodermatitis Clinical Trial
Official title:
Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT04593914 -
A Novel Skin Barrier Protectant for Acute Radiodermatitis
|
N/A | |
| Completed |
NCT06133218 -
Patient Reported Outcomes Using Mepitel Film During Radiotherapy
|
N/A | |
| 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 |