Status:

COMPLETED

Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

Lead Sponsor:

University of Brasilia

Conditions:

Radiodermatitis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the prevention of radiodermatitis in patients with breast cancer or head and neck cancer undergoing radiotherapy. Prop...

Detailed Description

It is considered that patients undergoing radiotherapy in use gel based on C. recutita or use of cream based urea three times a day, concomitant radiotherapy, would present the following hypotheses: ...

Eligibility Criteria

Inclusion

  • Being an adult, over the age of 18 years old;
  • Owning diagnosis of malignant breast or head and neck;
  • Being first referred to the radiotherapy protocol;
  • Agree to participate, expressing his acceptance by signing the Informed Consent Form (ICF);
  • Present absence of dermatitis to initiation of radiotherapy;
  • Demonstrate understanding of and conditions to continue the intervention in their home environment when needed.

Exclusion

  • Reports of previous hypersensitivity reaction or presentation, during the research, adverse reaction to chamomile or any plant of the Asteraceae or compositae family, or urea;
  • Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis;
  • Withdrawal of the patient to remain in the study, independent of time.

Key Trial Info

Start Date :

July 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2017

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT02247830

Start Date

July 1 2015

End Date

July 1 2017

Last Update

October 8 2020

Active Locations (1)

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1

University Hospital of Brasília

Brasília, Brazil