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

NCT ID: NCT02251392

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Radiodermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Chamomila recutita Gel

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Chamomila recutita Infuse

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Urea cream based

Intervention Type DRUG

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

Interventions

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Chamomila recutita Gel

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

Intervention Type OTHER

Chamomila recutita Infuse

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

Intervention Type OTHER

Urea cream based

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

Intervention Type DRUG

Other Intervention Names

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Chamomile Gel, Chamomila recutita gel Chamomile Infuse, Chamomila recutita infuse Urea cream

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Brasilia

OTHER

Sponsor Role lead

Responsible Party

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PAULA ELAINE DINIZ DOS REIS

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elaine B Ferreira, Nurse

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Priscila MS Bontempo, Nurse

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Brasilia

Marcia A Ciol, Biostatistcs

Role: STUDY_DIRECTOR

University of Washington

Karine RM Silva, Nurse

Role: STUDY_CHAIR

University of Brasilia

Carlos J Sacramento, Nurse

Role: STUDY_CHAIR

University of Brasilia

Paula ED Reis, PhD, Nurse

Role: STUDY_DIRECTOR

University of Brasilia

Samuel R Avelino, MP

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Brasilia

Leandro X Cardoso, Physics

Role: STUDY_CHAIR

University of Brasilia

Luis FO Silva, MP

Role: STUDY_CHAIR

University Hospital of Brasilia

References

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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.

Reference Type BACKGROUND
PMID: 21412623 (View on PubMed)

Other Identifiers

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UBrasilia

Identifier Type: -

Identifier Source: org_study_id