Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis

Study Overview
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Brief Summary
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This study aims to evaluate therapeutics interventions in radiodermatitis in patients with breast or head and neck cancer. The data collect is going to begin after determining the better dose in a dose-response curve that is being conduct now in the same institution. 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).

Detailed Description
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Hypothesis: Chamomila gel is more effective than urea (usual care); Chamomila infuse is more effective than urea (usual care); Chamomila gel is more effective than chamomila infuse; Chamomila infuse is more effective than chamomila gel; Chamomila gel is as effective than urea (usual care); Chamomila infuse is as effective than urea (usual care); Chamomila gel is as effective than chamomila infuse; Chamomila infuse is as effective than chamomila gel.

Official Title
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Evaluation of Therapeutic Efficacy in Use of Chamomila Gel, Chamomila Infuse and Urea in Patients With Breast or Head and Neck Cancer That Developed Radiodermatitis

Conditions
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Radiodermatitis

Intervention / Treatment
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* Other: Chamomila recutita Gel
* Other: Chamomila recutita Infuse
* Drug: Urea cream based


Participation Criteria
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Eligibility Criteria
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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; Presenting radiodermatitis grades 1 or 2, second RTOG score, in the place where is receiving radiation therapy; No history of previous hypersensitivity reaction to chamomile or any plant of the Asteraceae or Compositae family or Urea; Demonstrate understanding to continue the intervention in their home environment when necessary. Exclusion Criteria: Medical prescription, during the process of data collection, some kind of intervention to prevent radiodermatitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chamomila recutita Gel<br>Experimental Group 1 - patients will apply the gel since the begging of radiodermatitis, three times a day. The dose is being determined in a Phase II study that is being conducted. Topical application of gel is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it. | Other: Chamomila recutita Gel<br>* Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve<br>* Other names: Chamomile Gel, Chamomila recutita gel;|
| Experimental: Chamomila recutita Infuse 2,5%<br>Experimental Group 2 - patients will apply the infuse since the begging of radiodermatitis, three times a day. The dose of 2,5% was determined before in a Phase II study. Radiodermatitis grade and intensity is going to be evaluated. Topical application of the infuse is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it. | Other: Chamomila recutita Infuse<br>* chamomila infuse in a concentration of 2,5% already determined in a dose response curve<br>* Other names: Chamomile Infuse, Chamomila recutita infuse;|
| Active Comparator: Urea cream based<br>Control Group - usual care to treat radiodermatitis, patients will apply the infuse since the begging of radiodermatitis, three times a day. Radiodermatitis grade and intensity is going to be evaluated. Topical application of urea is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it. | Drug: Urea cream based<br>* Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care<br>* Other names: Urea cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the severity of radiodermatitis, according to the RTOG score. | This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Dose | radiation total dose and fraction | 5 weeks | 
| Radiodermititis Cure | The time that pacient don´t have more the radiodermititis | 8 weeks | 
| Time to reduce the severity of radiodermatitis | This outcome is going to be evaluated weekly by the analisys of the time of reduce the signs and symptoms of radiodermititis ant the RTOG score | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chamomilla, matricaria, chamomile, chamomila, recutita, Breast Neoplasms, head and neck neoplasms, radiotherapy