NCT02251392

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Radiodermatitis

Interventions

Type	Name	Description
OTHER	Chamomila recutita Gel	Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve
OTHER	Chamomila recutita Infuse	chamomila infuse in a concentration of 2,5% already determined in a dose response curve
DRUG	Urea cream based	Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2014-09-29
• Last updated: 2015-12-02