RBR-7zsggy2 Red light in skin healing of cancer patients

Date of registration: 03/02/2024 ^(mm/dd/yyyy)
Last approval date : 03/02/2024 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1304-9019

• Public title:

  en

  Red light in skin healing of cancer patients

  pt-br

  Luz vermelha na cicatrização de pele de pacientes com Câncer

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 48881321.4.0000.5346
    Issuing authority: Plataforma Brasil
  • 6.440.265
    Issuing authority: Comitê de Ética e Pesquisa da Universidade Federal de Santa Maria

Sponsors

• Primary sponsor: Universidade Federal de Santa Maria
• Secondary sponsor:
  • Institution: Universidade Federal de Santa Maria
• Supporting source:
  • Institution: Universidade Federal de Santa Maria

Health conditions

• Health conditions:

  en

  Radiodermatitis

  pt-br

  Radiodermatite

• General descriptors for health conditions:

  en

  E02.815 Radiotherapy

  pt-br

  E02.815 Radioterapia

• Specific descriptors:

  en

  C17.800.174.826 Radiodermatitis

  pt-br

  C17.800.174.826 Radiodermatite

Interventions

• Interventions:

  en

  This is a two-arm, double-blind, randomized controlled clinical study. Patients diagnosed with radiodermatitis will be divided into two groups. Experimental group: 40 patients will receive treatment with application of photobiomodulation with an energy density of 4J/cm² per point, twice a week, for 3 weeks. Control group: 40 patients with radiodermatitis will not receive photobiomodulation

  pt-br

  Trata-se de um estudo clínico randomizado controlado de dois braços, duplo-cego. Os pacientes diagnosticados com radiodermite serão divididos em dois grupos. Grupo experimental: 40 pacientes receberão tratamento com aplicação de fotobiomodulação com densidade de energia de 4J/cm² por ponto, 2 vezes por semana, durante 3 semanas. Grupo controle: 40 pacientes com radiodermite não receberão fotobiomodulação

• Descriptors:

  en

  E02.594.540 Low-Level Light Therapy

  pt-br

  E02.594.540 Terapia com Luz de Baixa Intensidade

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 09/01/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  80	F	18 Y	0

• Inclusion criteria:

  en

  Individuals of both sexes; cancer and ending with radiotherapy; I tend to develop radiodermite in any gray

  pt-br

  Indivíduos de ambos os sexos; acometidos pelo câncer e que finalizaram a radioterapia; tendo desenvolvido radiodermite em qualquer grau

• Exclusion criteria:

  en

  Minors under 18 years of age; metastase na pele; concomitant chemotherapy; infection in the region to be treated; história de doenças de pele ou autoimmunes; history of photosensitivity; inability to answer questions

  pt-br

  Menores de 18 anos; metástase na pele; quimioterapia concomitante; infecção na região a ser tratada; história de doenças de pele ou autoimunes; história de fotossensibilidade; incapacidade de responder questionários

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  It is expected that the intervention group will have a faster recovery from damaged skin due to radiodermite, when compared to the control group. The degree of radiodermite will be evaluated by the Radiation Therapy Oncology Group scale

  pt-br

  Espera-se que o grupo intervenção tenha mais rápida recuperação da pele afetada pela radiodermite, quando comparado com o grupo controle. O grau de radiodermite será avaliado pela escala Radiation Therapy Oncology Group

• Secondary outcomes:

  en

  Expect to promote better quality of life specific dermatologically endorsed questionnaire Skindex-16

  pt-br

  Espera-se promover a melhora da qualidade de vida dermatológica específica avaliada pelo questionário Skindex-16

Contacts

• Public contact
  • Full name: Hedioneia Maria Foletto Pivetta
  • • Address: Avenida Roraima, n° 1000
    • City: Santa Maria / Brazil
    • Zip code: 97105-900
  • Phone: +55-55-999716183
  • Email: hedioneia@yahoo.com.br
  • Affiliation: Universidade Federal de Santa Maria
   
• Scientific contact
  • Full name: Hedioneia Maria Foletto Pivetta
  • • Address: Avenida Roraima, n° 1000
    • City: Santa Maria / Brazil
    • Zip code: 97105-900
  • Phone: +55-55-999716183
  • Email: hedioneia@yahoo.com.br
  • Affiliation: Universidade Federal de Santa Maria
   
• Site contact
  • Full name: Hedioneia Maria Foletto Pivetta
  • • Address: Avenida Roraima, n° 1000
    • City: Santa Maria / Brazil
    • Zip code: 97105-900
  • Phone: +55-55-999716183
  • Email: hedioneia@yahoo.com.br
  • Affiliation: Universidade Federal de Santa Maria
   

Additional links:

• Download in ICTRP format