RBR-7yygb2 Changes in tissue electrical resistance as an indicator of radiotherapy-induced tissue alterations

Date of registration: 09/18/2018 ^(mm/dd/yyyy)
Last approval date : 02/17/2025 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1214-7398

• Public title:

  en

  Changes in tissue electrical resistance as an indicator of radiotherapy-induced tissue alterations

  pt-br

  Alteração na resistência elétrica dos tecidos como indicador das mudanças causadas pela radioterapia

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 80731617.0.0000.5146
    Issuing authority: Plataforma Brasil
  • 2.536.161
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Estadual de Montes Claros

Sponsors

• Primary sponsor: André Luiz Sena Guimarães
• Secondary sponsor:
  • Institution: Universidade Estadual de Montes Claros
• Supporting source:
  • Institution: Universidade Estadual de Montes Claros

Health conditions

• Health conditions:

  en

  Mucositis

  pt-br

  Mucosite

• General descriptors for health conditions:

  en

  C07 Stomatognathic diseases

  pt-br

  C07 Doenças estomatognáticas

• Specific descriptors:

  en

  C06.405.205.798 Mucositis

  pt-br

  C06.405.205.798 Mucosite

Interventions

• Interventions:

  en

  This double-blind, prospective, diagnostic, randomized controlled diagnose study followed the Standards for Reporting of Diagnostic Accuracy criteria and included 135 participants. The study aimed to evaluate tissue electrical properties in patients undergoing radiotherapy. The case group consisted of individuals with squamous cell carcinoma in the head and neck receiving three-dimensional conformal radiotherapy for squamous cell carcinoma in the head and neck region. In contrast, the control group included patients receiving radiotherapy for cancers of the bladder, rectum, breast, or cervix. The allocation ratio was 1:1.25, with randomization ensuring that neither the participants nor the care providers knew the assigned interventions. Both groups were blinded to the measured electrical parameters. The study recruiter and the statistician were not involved in patient care, further maintaining allocation concealment. Participants in both groups had tissue electrical properties, including impedance, resistance, reactance, phase angle, and capacitance, measured weekly from the start of radiotherapy, with a total follow-up period of approximately 60 days for the case group. Oral mucositis was graded weekly according to the World Health Organization criteria, and electrical resistance properties were measured using tetrapolar bioimpedance techniques. Statistical analyses, including receiver operating characteristic curves and Pearson correlation, identified predictive indicators of oral mucositis. Significant differences were observed between the case and control groups after one week of radiotherapy

  pt-br

  Este estudo diagnóstico duplo-cego, prospectivo, diagnóstico, randomizado e controlado seguiu os critérios dos Padrões para Relatórios de Precisão Diagnóstica e incluiu 135 participantes. O estudo teve como objetivo avaliar propriedades elétricas teciduais em pacientes submetidos à radioterapia. O grupo caso foi composto por indivíduos com carcinoma espinocelular de cabeça e pescoço recebendo radioterapia conformada tridimensional para carcinoma espinocelular de cabeça e pescoço. Em contraste, o grupo controle incluiu pacientes que receberam radioterapia para câncer de bexiga, reto, mama ou colo do útero. A proporção de alocação foi de 1:1,25, com a randomização garantindo que nem os participantes nem os prestadores de cuidados conhecessem as intervenções designadas. Ambos os grupos foram blindados para os parâmetros elétricos medidos. O recrutador do estudo e o estatístico não estiveram envolvidos no atendimento ao paciente, mantendo ainda mais o sigilo da alocação. Os participantes de ambos os grupos apresentaram propriedades elétricas dos tecidos, incluindo impedância, resistência, reatância, ângulo de fase e capacitância, medidas semanalmente desde o início da radioterapia, com período total de acompanhamento de aproximadamente 60 dias para o grupo caso. A mucosite oral foi graduada semanalmente de acordo com os critérios da Organização Mundial da Saúde, e as propriedades de resistência elétrica foram medidas por meio de técnicas de bioimpedância tetrapolar. Análises estatísticas, incluindo curvas receiver Operating Characteristic e correlação de Pearson, identificaram indicadores preditivos de mucosite oral. Diferenças significativas foram observadas entre os grupos caso e controle após uma semana de radioterapia

• Descriptors:

  en

  G01.358.500.249.277.350 Electric Impedance

  pt-br

  G01.358.500.249.277.350 Impedância Elétrica

Recruitment

• Study status: Terminated
• Countries
  • Brazil
• Date first enrollment: 03/19/2018 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  135	-	18 Y	0

• Inclusion criteria:

  en

  The criteria for inclusion in the study covered adults over 18 years of age of both sexes with a confirmed histopathological diagnosis of head and neck squamous cell carcinoma (HNSCC) in locations such as the base of the tongue, other or unspecified parts of the tongue, gums, floor of the mouth, palate, other parts or unspecified parts of the mouth, tonsils, oropharynx, pyriform sinus, hypopharynx and other ill-defined locations in the lip, oral cavity or pharynx, as well as patients with a confirmed histopathological diagnosis of other types of cancer in regions such as the prostate, urinary bladder, rectum, anus, breast and cervix, including prostate adenocarcinoma, metastasis in other organs of the urinary system, carcinoma in situ of the prostate , penile cancer, squamous cell carcinoma of the anal canal, squamous cell carcinoma of the cervix, adenocarcinoma of the cervix, esophageal cancer, ductal carcinoma in situ of the breast or others specified or unspecified malignant neoplasms. All participants, regardless of cancer type, were receiving 3D conformal radiotherapy (3D-RT), alone or in combination with chemotherapy

  pt-br

  Adult patients over 18 years of age (both sexes) with a confirmed histopathological diagnosis of head and neck squamous cell carcinoma in areas such as the base of the tongue, unspecified tongue, gums, floor of the mouth, palate, unspecified mouth, tonsils, oropharynx, pyriform sinus, hypopharynx, lip or pharynx not otherwise specified; confirmed histopathological diagnosis of prostate adenocarcinoma, metastasis in organs of the urinary system, carcinoma in situ of the prostate, penile cancer, squamous cell carcinoma of the anal canal, carcinoma or adenocarcinoma of the cervix, ductal carcinoma in situ of the breast or malignant neoplasms specified or not specified; treatment with 3D conformal radiotherapy alone or combined with chemotherapy

• Exclusion criteria:

  en

  patients who had already undergone radiotherapy for head and neck cancer; presence of oral mucositis at the beginning of the study; use of pacemakers; refusal to participate; history of alcohol or drug abuse; diagnosis of cardiac, renal, gastrointestinal, hepatic, pulmonary, neurological, psychiatric, hematological or metabolic diseaes

  pt-br

  pacientes que já haviam passado por radioterapia para cânceres de cabeça e pescoço; presença de mucosite oral no início do estudo; uso de marcapassos; recusa em participar; histórico de abuso de álcool ou drogas; diagnósticos de patologias cardíacas, renais, gastrintestinais, hepáticas, pulmonares, neurológicas, psiquiátricas, hematológicas ou metabólicas

Study type

• Study design:

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

Outcomes

• Primary outcomes:

  en

  expected outcome 1 is to find changes in the impedance, resistance, reactance, phase angle and capacitance modules after radiotherapy

  pt-br

  O desfecho esperado 1 espera se encontrar alteração alteração nos módulos de impedância, resistência, reatância, ângulo de fase e capacitância após radioterapia

  es

  El resultado esperado 1 es encontrar cambios en los módulos de impedancia, resistencia, reactancia, ángulo de fase y capacitancia después de la radioterapia.

  en

  Outcome found 1 there is an association between an increase in the values ​​of impedance modules, resistance, reactance, phase angle and capacitance with the appearance of mucositis

  pt-br

  Desfecho encontrado 1 existe associação entre aumento nos valores de módulos de impedância, resistência, reatância, ângulo de fase e capacitância com o aparecimento de mucosite

  es

  Resultado encontrado 1 existe asociación entre un aumento en los valores de módulos de impedancia, resistencia, reactancia, ángulo de fase y capacitancia con la aparición de mucositis

• Secondary outcomes:

  en

  expected outcome 2 is to find relationship among changes in the impedance, resistance, reactance, phase angle, capacitance modules and oral mucositis

  pt-br

  o resultado esperado 2 é encontrar relação entre mudanças na impedância, resistência, reatância, ângulo de fase, módulos de capacitância e mucosite oral

  es

  El resultado esperado 2 es encontrar relación entre los cambios en la impedancia, resistencia, reactancia, ángulo de fase, módulos de capacitancia y mucositis oral

  en

  Outcome found 2 there is an association among the values ​​of impedance modules, resistance, reactance, phase angle, capacitance and the appearance of mucositis

  pt-br

  Resultado encontrado 2 existe uma associação entre os valores dos módulos de impedância, resistência, reatância, ângulo de fase, capacitância e aparecimento de mucosite

  es

  Resultado encontrado 2 existe asociación entre los valores de módulos de impedancia, resistencia, reactancia, ángulo de fase, capacitancia y la aparición de mucositis

Contacts

• Public contact
  • Full name: Andre Luiz Sena Guimarães
  • • Address: Av Cula Mangabeira, 562, Laboratório de Pesquisa em Saúde, Sala 1, Bairro Santo Expedito
    • City: Montes Claros / Brazil
    • Zip code: 39400-632
  • Phone: +55(038)988313705
  • Email: andreluizguimaraes@gmail.com
  • Affiliation: Universidade Estadual de Montes Claros
   
• Scientific contact
  • Full name: Andre Luiz Sena Guimarães
  • • Address: Av Cula Mangabeira, 562, Laboratório de Pesquisa em Saúde, Sala 1, Bairro Santo Expedito
    • City: Montes Claros / Brazil
    • Zip code: 39400-632
  • Phone: +55(038)988313705
  • Email: andreluizguimaraes@gmail.com
  • Affiliation: Universidade Estadual de Montes Claros
   
• Site contact
  • Full name: Andre Luiz Sena Guimarães
  • • Address: Av Cula Mangabeira, 562, Laboratório de Pesquisa em Saúde, Sala 1, Bairro Santo Expedito
    • City: Montes Claros / Brazil
    • Zip code: 39400-632
  • Phone: +55(038)988313705
  • Email: andreluizguimaraes@gmail.com
  • Affiliation: Universidade Estadual de Montes Claros
   

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