Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Prognosis of Head and Neck Cancer Patients Receiving Curative Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Care (in control arm), Transcutaneous Electrical Nerve Stimulation, Far-Infrared Therapy.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer (H&N). Basic parameters: 30 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
- 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.]
Secondary outcome measures (4)
- 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.]
- 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.]
- 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.]
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — Hualien City
Identifiers
NCT: NCT07689019 · IRB113-052-A-CCRT