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

Sponsor

University of Brasilia (Other)

Overall Status

Unknown status

CT.gov ID

NCT02251392

Collaborator

University of Washington (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

100

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Radiodermatitis	Other: Chamomila recutita Gel Other: Chamomila recutita Infuse Drug: Urea cream based	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chamomila recutita Gel 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.	Other: Chamomila recutita Gel Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve Other Names: Chamomile Gel, Chamomila recutita gel
Experimental: Chamomila recutita Infuse 2,5% 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.	Other: Chamomila recutita Infuse chamomila infuse in a concentration of 2,5% already determined in a dose response curve Other Names: Chamomile Infuse, Chamomila recutita infuse
Active Comparator: Urea cream based 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.	Drug: Urea cream based Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care Other Names: Urea cream

Arm

Intervention/Treatment

Experimental: Chamomila recutita Gel

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.

Other: Chamomila recutita Gel

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

Other Names:

Chamomile Gel, Chamomila recutita gel

Experimental: Chamomila recutita Infuse 2,5%

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.

Other: Chamomila recutita Infuse

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

Other Names:

Chamomile Infuse, Chamomila recutita infuse

Active Comparator: Urea cream based

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.

Drug: Urea cream based

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

Other Names:

Urea cream

Outcome Measures

Primary Outcome Measures

Reduction of the severity of radiodermatitis, according to the RTOG score. [5 weeks]
This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Brasilia
University of Washington
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Principal Investigator: Elaine B Ferreira, Nurse, University of Brasilia
Principal Investigator: Priscila MS Bontempo, Nurse, University Hospital of Brasilia
Study Director: Marcia A Ciol, Biostatistcs, University of Washington
Study Chair: Karine RM Silva, Nurse, University of Brasilia
Study Chair: Carlos J Sacramento, Nurse, University of Brasilia
Study Director: Paula ED Reis, PhD, Nurse, University of Brasilia
Principal Investigator: Samuel R Avelino, MP, University Hospital of Brasilia
Study Chair: Leandro X Cardoso, Physics, University of Brasilia
Study Chair: Luis FO Silva, MP, University Hospital of Brasilia