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Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Prognosis of Head and Neck Cancer Patients Receiving Curative Treatment

30 de junho de 2026 atualizado por: Buddhist Tzu Chi General Hospital

Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short-Term Prognosis of Head and Neck Cancer Patients Receiving Curative Treatment: A Randomized Controlled Trial

This clinical trial aims to evaluate whether far infrared radiation therapy and transcutaneous electrical nerve stimulation can reduce treatment-related side effects in patients with head and neck cancer undergoing concurrent chemoradiotherapy.

The primary objectives of this study are to determine whether far infrared radiation therapy and transcutaneous electrical nerve stimulation can improve shoulder pain and disability, cervical range of motion, maximum interincisal distance, oral mucositis, systemic inflammation, and chemotherapy-induced nausea and vomiting.

Participants will be randomly assigned to one of three groups: Group A will receive standard care (control group); Group B will receive standard care plus transcutaneous electrical nerve stimulation; and Group C will receive standard care plus far infrared radiation therapy combined with transcutaneous electrical nerve stimulation.

The intervention will be administered over two cycles of concurrent chemoradiotherapy, for a total of 10 intervention days. During each treatment cycle, participants in the intervention groups will receive the assigned treatment once every morning and once every evening for five consecutive days. Outcome assessments will be performed at three time points during each treatment cycle: before the intervention on Day 1 (baseline), after the intervention on Day 3, and after the intervention on Day 5.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

102

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Taiwan
    • Hualien County
      • Hualien City, Hualien County, Taiwan, 97002
        • Recrutamento
        • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • Contato:
        • Investigador principal:
          • LING-JIE CHEN, BSN

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Adults aged 30 to 85 years.
  2. Histologically confirmed head and neck cancer.
  3. Scheduled to concurrent chemoradiotherapy.
  4. Able to communicate verbally or in writing, willing to complete study questionnaires, and able to comply with all study procedures.

Exclusion Criteria:

  1. Presence of wounds or skin lesions at the sites where the transcutaneous electrical nerve stimulation electrodes will be applied.
  2. Contraindications to transcutaneous electrical nerve stimulation, including a history of epilepsy, brain tumor, arteriovenous malformation, implanted cardiac pacemaker, or implantable cardioverter-defibrillator, due to the potential risk of electrical stimulation interfering with the underlying medical condition.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Cuidado padrão
Outro: Standard Care (in control arm)
Participants will receive standard care during concurrent chemoradiotherapy according to institutional practice. Standard care includes routine pre-treatment evaluation, radiotherapy followed by chemotherapy, post-radiotherapy cold compresses applied to the irradiated area three times daily, and standard supportive care during chemotherapy.
Experimental: Standard Care plus Transcutaneous Electrical Nerve Stimulation
Outro: Standard Care (in control arm)
Participants will receive standard care during concurrent chemoradiotherapy according to institutional practice. Standard care includes routine pre-treatment evaluation, radiotherapy followed by chemotherapy, post-radiotherapy cold compresses applied to the irradiated area three times daily, and standard supportive care during chemotherapy.
Dispositivo: Transcutaneous Electrical Nerve Stimulation
Participants will receive transcutaneous electrical nerve stimulation twice daily (morning and evening) for five consecutive days during each concurrent chemoradiotherapy cycle. Each treatment session will last 20 minutes. Self-adhesive electrode pads will be applied bilaterally to the Fengchi (GB20), Neiguan (PC6), and Hegu (LI4) acupoints.
Experimental: Standard Care plus Transcutaneous Electrical Nerve Stimulation Combined with Far-Infrared Therapy
Outro: Standard Care (in control arm)
Participants will receive standard care during concurrent chemoradiotherapy according to institutional practice. Standard care includes routine pre-treatment evaluation, radiotherapy followed by chemotherapy, post-radiotherapy cold compresses applied to the irradiated area three times daily, and standard supportive care during chemotherapy.
Dispositivo: Transcutaneous Electrical Nerve Stimulation
Participants will receive transcutaneous electrical nerve stimulation twice daily (morning and evening) for five consecutive days during each concurrent chemoradiotherapy cycle. Each treatment session will last 20 minutes. Self-adhesive electrode pads will be applied bilaterally to the Fengchi (GB20), Neiguan (PC6), and Hegu (LI4) acupoints.
Dispositivo: Far-Infrared Therapy
Participants will receive far-infrared therapy twice daily (morning and evening) for five consecutive days during each concurrent chemoradiotherapy cycle. Each treatment session will last 30 minutes. Participants will be placed in a supine position with the dorsum of both feet exposed. Far-infrared irradiation will be applied bilaterally to the Taichong (LR3) acupoints, with the radiator positioned approximately 20 cm above the treatment sites.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Shoulder Pain and Disability
Prazo: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI is a validated questionnaire that evaluates the severity of shoulder pain and the impact of shoulder dysfunction on activities of daily living. Higher scores indicate greater pain and disability.
Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Cervical Range of Motion
Prazo: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Cervical range of motion (ROM) will be measured using a goniometer and recorded in degrees. Measurements will include cervical flexion, extension, left and right lateral flexion, and left and right rotation to evaluate cervical mobility in patients with head and neck cancer.
Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Maximum Interincisal Distance
Prazo: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Maximum interincisal distance (MID) will be measured as the maximum distance between the upper and lower incisors during maximal mouth opening. For participants with natural teeth or dentures, the distance between the upper and lower central incisors will be measured. For edentulous participants, the distance between the upper and lower alveolar ridges will be measured. Measurements will be recorded in millimeters (mm) to evaluate mouth opening function.
Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Oral Mucositis
Prazo: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Oral mucositis will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. The severity of oral mucositis will be graded according to the CTCAE grading system, with higher grades indicating more severe mucosal toxicity.
Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Inflammatory Biomarkers
Prazo: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Inflammatory biomarkers will be assessed using laboratory blood tests. Complete blood count analysis will be performed to measure white blood cell count, red blood cell count, platelet count, neutrophil-to-lymphocyte ratio, and platelet-to-lymphocyte ratio for evaluating systemic inflammatory status.
Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Nausea and Vomitin
Prazo: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
Nausea and vomiting will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. The severity of nausea and vomiting will be graded according to the CTCAE grading system, with higher grades indicating more severe symptoms.
Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Buddhist Tzu Chi General Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de maio de 2024

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

30 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de junho de 2026

Primeira postagem (Real)

7 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB113-052-A-CCRT

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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