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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer (H&N)
• Intervention / Treatment: Other: Standard Care (in control arm); Device: Transcutaneous Electrical Nerve Stimulation; Device: Far-Infrared Therapy

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hualien County
    • Hualien City, Hualien County, Taiwan, 97002
      • Recruiting
      • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
      • Contact: Department of Medical Research; Phone Number: 886-3-8561825; Email: hlmweb@tzuchi.com.tw
      • Principal Investigator: LING-JIE CHEN, BSN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care	Other: 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	Other: 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.; Device: 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	Other: 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.; Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Interincisal Distance	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	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	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	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.

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: transcutaneous electrical nerve stimulation; Head and Neck Cancer (H&N); far infrared
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Quality of Health Care; Physical Therapy Modalities; Quality Indicators, Health Care; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Standard of Care; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: IRB113-052-A-CCRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No