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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: 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

Brief Summary: 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 Summary:

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.


Sponsor: University of Brasilia

Current Primary Outcome: Reduction of the severity of radiodermatitis, according to the RTOG score. [ Time Frame: 5 weeks ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Radiation Dose [ Time Frame: 5 weeks ]
    radiation total dose and fraction
  • Radiodermititis Cure [ Time Frame: 8 weeks ]
    The time that pacient don´t have more the radiodermititis
  • Time to reduce the severity of radiodermatitis [ Time Frame: 5 weeks ]
    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


Original Secondary Outcome: Same as current

Information By: University of Brasilia

Dates:
Date Received: September 25, 2014
Date Started: August 2015
Date Completion: December 2016
Last Updated: November 30, 2015
Last Verified: November 2015