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Foot Reflexology and Ta-VNS for Symptom Management in Head and Neck Cancer During CCRT
Sponsor: Tzu Chi University
Summary
Head and neck cancer (HNC) patients undergoing concurrent chemoradiotherapy (CCRT) frequently experience pain, xerostomia, fatigue, sleep disturbance, and other treatment-related toxicities that impair quality of life and treatment adherence, with incomplete relief from current supportive care. This randomized, single-blind, sham-controlled trial evaluates whether foot reflexology (FR), transcutaneous auricular vagus nerve stimulation (ta-VNS), and auricular acupressure (AA) reduce pain, xerostomia, fatigue, sleep disturbance, and treatment-related symptoms in HNC patients receiving cisplatin-based CCRT, compared with usual care. Participants are randomized to a foot reflexology group, an auricular vagus nerve stimulation group (each with true and sham subgroups), or a usual-care control group, and are followed at baseline and weeks 1, 2, and 4.
Official title: Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Pain, Xerostomia, Fatigue, Sleep, and Treatment-Related Symptoms in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy: A Randomized, Single-Blind, Sham-Controlled Trial
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-07-13
Completion Date
2028-12-31
Last Updated
2026-07-24
Healthy Volunteers
No
Interventions
True Foot Reflexology
Twice weekly, 20 min, over 2 weeks. Three phases: relaxation (diaphragm, brain, spine zones, 3 min); head-neck function and gastrointestinal regulation (upper/lower GI, thyroid, adrenal zones, 10 min); circulation/detoxification (kidney, lymphatic zones, 7 min).
Sham Foot Reflexology
Light touch on non-specific foot areas without
True ta-VNS
Left tragus, cymba conchae, cavum conchae; 250 µs, 25 Hz, 0.5-5 mA individualized to tingling, 30 s on/off; twice weekly, 20 min, 2 weeks. Device: Hong-Tai mid-frequency electrotherapy stimulator, model HT66B (TFDA license no. 000637), used off-label for auricular vagus nerve stimulation.
Sham ta-VNS
Left earlobe, 0.5 mA, otherwise identical parameters.
True Auricular Acupressure
Magnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; 3×/day, \~30 s per point; changed every 2-3 days.
Sham Auricular Acupressure
Beads at left earlobe (non-vagal regions), same frequency/duration.
Usual Care
Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.
Locations (1)
Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
Hualien City, Taiwan