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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Shoulder Pain and Disability [Срок оценки: 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 [Срок оценки: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.]

Вторичные конечные точки (4)

• Maximum Interincisal Distance [Срок оценки: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.]
• Oral Mucositis [Срок оценки: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.]
• Inflammatory Biomarkers [Срок оценки: 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 [Срок оценки: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Тайвань · 1 центр

• Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — Hualien City

Идентификаторы

NCT: NCT07689019 · IRB113-052-A-CCRT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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