Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Head and Neck Neoplasms

Radiodermatitis

Dermatitis

Skin Diseases

Radiation Injuries

Anti-Infective Agents

All Drugs and Chemicals

Herbal and Botanical

Carbamide Peroxide

Chamomile

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.

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.

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.

Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve

Chamomila recutita Gel

chamomila infuse in a concentration of 2,5% already determined in a dose response curve

Chamomila recutita Infuse

Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care

Urea cream based

Elaine B Ferreira, Nurse

Priscila MS Bontempo, Nurse

Marcia A Ciol, Biostatistcs

Karine RM Silva, Nurse

Carlos J Sacramento, Nurse

Paula ED Reis, PhD, Nurse

Samuel R Avelino, MP

Leandro X Cardoso, Physics

Luis FO Silva, MP

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).

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.

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

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

This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score

The time that pacient don´t have more the radiodermititis

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis	NCT02251392	Radiodermatitis	Chamomila recut... Chamomila recut... Urea cream base...	18 Years -	University of Brasilia
Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis	NCT02251392	Radiodermatitis	Chamomila recut... Chamomila recut... Urea cream base...	18 Years -	University of Brasilia

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