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NCT Number: NCT07689019

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

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.

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Key information

Conditions

Head and Neck Cancer (H&N) Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Hualien County, 97002, Taiwan

Location status: Recruiting

Location contact

Department of Medical Research

CONTACT

[email protected]

886-3-8561825

LING-JIE CHEN, BSN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Presence of wounds or skin lesions at the sites where the transcutaneous electrical nerve stimulation electrodes will be applied.
  • 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.

Treatment and study plan

Standard Care (in control arm)

Other

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.

Transcutaneous electrical nerve stimulation

Device

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.

Far-Infrared Therapy

Device

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.

Primary outcomes

  1. Shoulder Pain and Disability

    Time frame: 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.

  2. Cervical Range of Motion

    Time frame: 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.

Secondary outcomes

  1. Maximum Interincisal Distance

    Time frame: 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.

  2. Oral Mucositis

    Time frame: 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.

  3. Inflammatory Biomarkers

    Time frame: 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.

  4. Nausea and Vomitin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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