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Clinical Trial 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).


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02251392
Study type Interventional
Source University of Brasilia
Contact
Status Enrolling by invitation
Phase Phase 3
Start date August 2015
Completion date December 2016

See also
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Not yet recruiting NCT04617730 - Efficacy of the Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold. Phase 1/Phase 2
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Completed NCT04239560 - Preventive Effect of Boron-based Gel on Radiation Dermatitis Phase 3
Completed NCT02249884 - Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis Phase 2
Withdrawn NCT04692389 - Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis. N/A
Enrolling by invitation NCT04067310 - Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis. N/A