AIM: 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. DESIGN: The study is a randomized controlled clinical trial. METHODS: We will recruit 48 individuals with head and neck cancer who will be starting theirradiotherapy 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. DISCUSSION: 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.
RCT Entities:
AIM: 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. DESIGN: 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. DISCUSSION: 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: Elaine B Ferreira; Marcia A Ciol; Amanda G de Meneses; Priscila de S M Bontempo; Jeanne M Hoffman; Paula E D Dos Reis Journal: Integr Cancer Ther Date: 2020 Jan-Dec Impact factor: 3.279