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

NCT02251392 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-12-02

No results posted yet for this study

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).

Conditions

  • Radiodermatitis

Interventions

OTHER

Chamomila recutita Gel

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

OTHER

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

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • University of Brasilia

    lead OTHER

Principal Investigators

  • Elaine B Ferreira, Nurse · University of Brasilia

  • Priscila MS Bontempo, Nurse · University Hospital of Brasilia

  • Marcia A Ciol, Biostatistcs · University of Washington

  • Karine RM Silva, Nurse · University of Brasilia

  • Carlos J Sacramento, Nurse · University of Brasilia

  • Paula ED Reis, PhD, Nurse · University of Brasilia

  • Samuel R Avelino, MP · University Hospital of Brasilia

  • Leandro X Cardoso, Physics · University of Brasilia

  • Luis FO Silva, MP · University Hospital of Brasilia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-07-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251392 on ClinicalTrials.gov