Clinical trial · Interventional
Management Radiodermatitis in Patients With Breast or Head and Neck Cancer
Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the prevention of radiodermatitis in patients with breast cancer or head and neck cancer undergoing radiotherapy. Prophylactic Trial will consist of a control group and two experimental groups, namely control group (usual care), Experimental Group 01 (usual care + topical application of the gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based cream). The doses used in the different compounds are being in test since february 2014 by a dose-response curve study, using 6 groups with three doses of urea cream and three doses of C. recutita gel. The study will be conducted at the Center for High Complexity Oncology at University Hospital of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according to established criteria to classify the effects of radiotherapy, which identifies grades 0, 1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiodermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chamomilla recutita gel | Other | — | UNRESOLVED |
| Urea cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1 Chamomilla recutita gel
- description
- Experimental Group 01: usual care + topical application of the gel recutita chamomile. Such intervention will be characterized by topical application of the gel C. recutita, concomitantly to the initiation of radiotherapy, should be applied on the irradiated three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).
- interventionNames
- Other: Chamomilla recutita gel
- type
- EXPERIMENTAL
- label
- 2 Urea cream
- description
- Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the area irradiated three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).
- interventionNames
- Drug: Urea cream
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Being an adult, over the age of 18 years old; * Owning diagnosis of malignant breast or head and neck; * Being first referred to the radiotherapy protocol; * Agree to participate, expressing his acceptance by signing the Informed Consent Form (ICF); * Present absence of dermatitis to initiation of radiotherapy; * Demonstrate understanding of and conditions to continue the intervention in their home environment when needed. Exclusion Criteria: * Reports of previous hypersensitivity reaction or presentation, during the research, adverse reaction to chamomile or any plant of the Asteraceae or compositae family, or urea; * Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis; * Withdrawal of the patient to remain in the study, independent of time.
References
Publications (0)
Data not yet available