About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Standard Care (in control arm)
- Transcutaneous Electrical Nerve Stimulation
- Far-Infrared Therapy