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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 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

102

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Taiwan
    • Hualien County
      • Hualien City, Hualien County, Taiwan, 97002
        • Rekrytering
        • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • Kontakt:
        • Huvudutredare:
          • LING-JIE CHEN, BSN

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Standardvård
Övrig: 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.
Experimentell: Standard Care plus Transcutaneous Electrical Nerve Stimulation
Övrig: 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.
Enhet: 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.
Experimentell: Standard Care plus Transcutaneous Electrical Nerve Stimulation Combined with Far-Infrared Therapy
Övrig: 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.
Enhet: 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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Shoulder Pain and Disability
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum Interincisal Distance
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

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Sponsor

Buddhist Tzu Chi General Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 maj 2024

Primärt slutförande (Beräknad)

31 december 2026

Avslutad studie (Beräknad)

31 december 2026

Studieregistreringsdatum

Först inskickad

30 juni 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

7 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB113-052-A-CCRT

Plan för individuella deltagardata (IPD)

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NEJ

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