title: Gel of chamomile vs. urea cream to prevent acute radiation dermatitis in patients with head and neck cancer: a randomized controlled trial.
abstract: OBJECTIVE
  To compare a gel made with chamomile (Chamomilla recutita) with a cream of urea as an intervention to delay the time to occurrence of radiation dermatitis.
  
  
  BACKGROUND
  Radiation dermatitis is one of the most common adverse effects of radiotherapy in patients with head and neck cancer. It is characterized by erythema, itching, pain, skin breakage and burning sensation, and there is no consensus on how to prevent it.
  
  
  METHODS
  The study is a randomized controlled clinical trial.
  
  
  METHODS
  We will recruit 48 individuals with head and neck cancer who will be starting their radiotherapy and randomize them to receive either gel of chamomile or cream of urea, as an intervention for prevention of radiation dermatitis. Social-demographic data will be collected at baseline, and clinical data will be collected before the initiation of radiotherapy. Participants will be followed weekly to assess development of radiation dermatitis. The protocol is funded by Conselho Nacional de Pesquisa e Desenvolvimento Científico (Brazil). The study was approved by a research ethics committee.
  
  
  CONCLUSIONS
  Given the clinical relevance of preventing radiation dermatitis and the lack of evidence supporting specific preventive interventions, it is important to study new products that might be efficacious to prevent this complication. This article presents the protocol of a randomized controlled trial comparing a gel made with chamomile (intervention) with a cream of urea (control) to prevent radiation dermatitis in patients with head and neck cancer undergoing radiotherapy.
authors.affiliation: University of Brasília, Brazil.
authors.forename: Elaine Barros
authors.initials: EB
authors.lastname: Ferreira
authors.affiliation: University of Washington, USA.
authors.forename: Marcia A
authors.initials: MA
authors.lastname: Ciol
authors.affiliation: University of Brasília, Brazil.
authors.forename: Christiane Inocêncio
authors.initials: CI
authors.lastname: Vasques
authors.affiliation: University Hospital of Brasília, Brazil.
authors.forename: Priscila de Souza Maggi
authors.initials: Pde S
authors.lastname: Bontempo
authors.affiliation: University of Brasília, Brazil.
authors.forename: Nayara Narley Pires
authors.initials: NN
authors.lastname: Vieira
authors.affiliation: University Hospital of Brasília, Brazil.
authors.forename: Luis Felipe Oliveira E
authors.initials: LF
authors.lastname: Silva
authors.affiliation: University Hospital of Brasília, Brazil.
authors.forename: Samuel Ramalho
authors.initials: SR
authors.lastname: Avelino
authors.affiliation: University Hospital of Brasília, Brazil.
authors.forename: Marcos Antônio
authors.initials: MA
authors.lastname: Dos Santos
authors.affiliation: University of Brasília, Brazil.
authors.forename: Paula Elaine Diniz
authors.initials: PE
authors.lastname: Dos Reis
mesh_terms: D000287:Administration, Topical; D001938:Brazil; D020843:Chamomile; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D011855:Radiodermatitis / Q000517:prevention & control*; D012107:Research Design; D014508:Urea
chemical_list: D014508:Urea
keywords: chamomile; head and neck cancer; nursing care; radiation dermatitis; skin care; urea