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

Primary Purpose

Radiodermatitis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Chamomila recutita Gel
Chamomila recutita Infuse
Urea cream based
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiodermatitis focused on measuring chamomilla, matricaria, chamomile, chamomila, recutita, Breast Neoplasms, head and neck neoplasms, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Chamomila recutita Gel

    Chamomila recutita Infuse 2,5%

    Urea cream based

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Radiation Dose
    radiation total dose and fraction
    Radiodermititis Cure
    The time that pacient don´t have more the radiodermititis
    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

    Full Information

    First Posted
    September 25, 2014
    Last Updated
    November 30, 2015
    Sponsor
    University of Brasilia
    Collaborators
    University of Washington, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02251392
    Brief Title
    Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Brasilia
    Collaborators
    University of Washington, Conselho Nacional de Desenvolvimento Científico e Tecnológico

    4. Oversight

    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Radiodermatitis
    Keywords
    chamomilla, matricaria, chamomile, chamomila, recutita, Breast Neoplasms, head and neck neoplasms, radiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chamomila recutita Gel
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Chamomila recutita Infuse 2,5%
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Urea cream based
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Chamomila recutita Gel
    Other Intervention Name(s)
    Chamomile Gel, Chamomila recutita gel
    Intervention Description
    Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve
    Intervention Type
    Other
    Intervention Name(s)
    Chamomila recutita Infuse
    Other Intervention Name(s)
    Chamomile Infuse, Chamomila recutita infuse
    Intervention Description
    chamomila infuse in a concentration of 2,5% already determined in a dose response curve
    Intervention Type
    Drug
    Intervention Name(s)
    Urea cream based
    Other Intervention Name(s)
    Urea cream
    Intervention Description
    Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care
    Primary Outcome Measure Information:
    Title
    Reduction of the severity of radiodermatitis, according to the RTOG score.
    Description
    This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    Radiation Dose
    Description
    radiation total dose and fraction
    Time Frame
    5 weeks
    Title
    Radiodermititis Cure
    Description
    The time that pacient don´t have more the radiodermititis
    Time Frame
    8 weeks
    Title
    Time to reduce the severity of radiodermatitis
    Description
    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
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elaine B Ferreira, Nurse
    Organizational Affiliation
    University of Brasilia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Priscila MS Bontempo, Nurse
    Organizational Affiliation
    University Hospital of Brasilia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marcia A Ciol, Biostatistcs
    Organizational Affiliation
    University of Washington
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Karine RM Silva, Nurse
    Organizational Affiliation
    University of Brasilia
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Carlos J Sacramento, Nurse
    Organizational Affiliation
    University of Brasilia
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Paula ED Reis, PhD, Nurse
    Organizational Affiliation
    University of Brasilia
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Samuel R Avelino, MP
    Organizational Affiliation
    University Hospital of Brasilia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Leandro X Cardoso, Physics
    Organizational Affiliation
    University of Brasilia
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Luis FO Silva, MP
    Organizational Affiliation
    University Hospital of Brasilia
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21412623
    Citation
    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. doi: 10.1590/s0104-11692011000100002.
    Results Reference
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    Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis

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