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

NCT07689019 | Recruiting

• 1 other identifier: IRB113-052-A-CCRT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer (H&N)

Keywords

Head and Neck Cancer (H&N); transcutaneous electrical nerve stimulation; far infrared

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Maximum Interincisal Distance

  Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.

• Oral Mucositis

  Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.

• Inflammatory Biomarkers

  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

  Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.

Study Arms (3)

Standard Care

ACTIVE COMPARATOR

Other: Standard Care (in control arm)

Standard Care plus Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL

Other: Standard Care (in control arm); Device: Transcutaneous Electrical Nerve Stimulation

Standard Care plus Transcutaneous Electrical Nerve Stimulation Combined with Far-Infrared Therapy

EXPERIMENTAL

Other: Standard Care (in control arm); Device: Transcutaneous Electrical Nerve Stimulation; Device: Far-Infrared Therapy

Interventions

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.

Standard Care; Standard Care plus Transcutaneous Electrical Nerve Stimulation; Standard Care plus Transcutaneous Electrical Nerve Stimulation Combined with Far-Infrared Therapy

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.

Standard Care plus Transcutaneous Electrical Nerve Stimulation; Standard Care plus Transcutaneous Electrical Nerve Stimulation Combined with Far-Infrared Therapy

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.

Standard Care plus Transcutaneous Electrical Nerve Stimulation Combined with Far-Infrared Therapy

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Hualien County, 97002, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Standard of Care; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of three parallel groups: standard care (control group), standard care plus transcutaneous electrical nerve stimulation, or standard care plus transcutaneous electrical nerve stimulation combined with far infrared radiation therapy. Participants will remain in their assigned group throughout the study. Primary and secondary outcome measures will be assessed at six predefined time points during two cycles of concurrent chemoradiotherapy.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)