RBR-108b5jqc Blue LED in the treatment of skin lesions caused by Radiotherapy

Date of registration: 02/08/2024 ^(mm/dd/yyyy)
Last approval date : 02/08/2024 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1302-4409

• Public title:

  en

  Blue LED in the treatment of skin lesions caused by Radiotherapy

  pt-br

  LED azul no tratamento de lesões de pele causadas pela Radioterapia

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 48881321.4.0000.5346
    Issuing authority: Plataforma Brasil
  • 4.878.739
    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

  E02.183.750 Antineoplastic Protocols

  pt-br

  E02.183.750 Protocolos Antineoplásicos

• Specific descriptors:

  en

  C17.800.174.826 Radiodermatitis

  pt-br

  C17.800.174.826 Radiodermatite

Interventions

• Interventions:

  en

  This is a randomized, carried out by a table of random numbers, double-blind clinical trial. Sample: patients diagnosed with cancer and indicated for radiotherapy treatment. Volunteers will be divided into two homogeneous groups, with 30 in each group. The blue LED group will receive the therapeutic radiodermatitis prevention protocol using blue LED daily and prior to the radiotherapy sessions, the dose used will be 18 J/cm². The control group will receive the protocol with the device turned off.

  pt-br

  Trata-se de um ensaio clínico randomizado realizado por uma tabela de números aleatórios, duplo cego. Amostra: pacientes com diagnóstico de câncer e indicação de tratamento por radioterapia. Os voluntários serão divididos em dois grupos homogêneos, com 30 em cada grupo. O grupo LED azul receberá o protocolo terapêutico de prevenção de radiodermite por LED azul diariamente e previamente às sessões de radioterapia, a dose utilizada será de 18 J/cm². O grupo controle receberá o protocolo com o aparelho desligado.

• 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: 05/01/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  60	-	18 Y	0

• Inclusion criteria:

  en

  Men and women; older than 18 years; diagnosed with cancer referred to the Santa Maria University Hospital physiotherapy outpatient clinic for physiotherapeutic treatment; with indication of radiotherapy

  pt-br

  Homens e mulheres; maiores de 18 anos; com diagnóstico de câncer encaminhados para o ambulatório de fisioterapia do Hospital Universitário de Santa Maria para tratamento fisioterapêutico; com indicação de radioterapia

• Exclusion criteria:

  en

  Unable to understand guidelines, such as those regarding the effects, protocol and care; volunteers who miss three more sessions; patients who have already received radiotherapy sessions; with skin cancer; pregnant women

  pt-br

  Incapazes de compreender as orientações, tais como os referentes aos efeitos, protocolo e cuidados; voluntários que faltarem mais três sessões; pacientes que já receberam sessões de radioterapia; com câncer de pele; gestantes

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 patients will not develop skin problems caused by radiotherapy evaluated by scale Radiation Therapy Oncology Group (RTOG)

  pt-br

  Espera-se que as pacientes não desenvolvam problemas de pele ocasionados pela radioterapia, avaliado pela escala Radiation Therapy Oncology Group (RTOG)

• Secondary outcomes:

  en

  It is hoped that radiodermatitis will not progress to more serious degrees evaluated by scale Radiation Therapy Oncology Group (RTOG)

  pt-br

  Espera-se que a radiodermite não evolua para graus mais graves, avaliado pela escala Radiation Therapy Oncology Group (RTOG)

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