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

November 30, 2015 updated by: PAULA ELAINE DINIZ DOS REIS, University of Brasilia

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Dose
Time Frame: 5 weeks
radiation total dose and fraction
5 weeks
Radiodermititis Cure
Time Frame: 8 weeks
The time that pacient don´t have more the radiodermititis
8 weeks
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
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Collaborators

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 Brasília
  • 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 Brasília
  • Study Chair: Leandro X Cardoso, Physics, University of Brasilia
  • Study Chair: Luis FO Silva, MP, University Hospital of Brasília

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBrasilia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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