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

Radiodermatitis Clinical Trial

— ChamomillaTH  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02251392
• Other study ID #: UBrasilia
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: September 25, 2014
• Last updated: November 30, 2015
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

• Radiodermatitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Brasilia	Conselho Nacional de Desenvolvimento Científico e Tecnológico, University of Washington

References & Publications (1)

Reis PE, Carvalho EC, Bueno PC, Bastos JK. Clinical application of Chamomilla recutita in phlebitis: dose response curve study. Rev Lat Am Enfermagem. 2011 Jan-Feb;19(1):3-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Radiation Dose	radiation total dose and fraction	5 weeks	Yes
Secondary	Radiodermititis Cure	The time that pacient don´t have more the radiodermititis	8 weeks	Yes
Secondary	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	Yes