Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Progno… (NCT07689019) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Prognosis of Head and Neck Cancer Patients Receiving Curative Treatment
Taiwan102 participantsStarted 2024-05-15
Plain-language 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.
Who can participate
Age range
30 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses far infrared rays and TENS (transcutaneous electrical nerve stimulation) to look at shoulder pain and neck movement during curative treatment for head and neck cancer — could either of those approaches interfere with my radiation or surgery in any way?
2Since this trial is listed as 'Phase NA,' meaning it doesn't fit the standard drug-trial phases, what does that tell us about how much safety and effectiveness data already exists for these techniques in people going through curative head and neck cancer treatment?
3The trial is measuring shoulder pain, disability, and cervical range of motion as its main outcomes — are those specific problems something I'm likely to face given my diagnosis and treatment plan, and would joining this study actually help track and address them for me?
4Would participating in this trial add extra visits, sessions, or equipment to my already demanding treatment schedule, and is that realistic given everything else I'll be managing during curative treatment?
5If I don't join this trial, are there standard-of-care options already available to help manage shoulder pain and neck stiffness after head and neck cancer treatment that we should consider first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Shoulder Pain and Disability
Timeframe: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.
2
Cervical Range of Motion
Timeframe: Baseline (Day 1 before intervention), Day 3 after intervention, and Day 5 after intervention during each of the two concurrent chemoradiotherapy cycles.