Foot Reflexology and Ta-VNS for Symptom Management in Head and Neck Cancer During CCRT

This is a three-arm parallel, repeated-measures randomized controlled trial conducted in the otolaryngology outpatient and inpatient settings of Hualien Tzu Chi Hospital. Eligible patients with pathologically confirmed HNC (clinical stage II-IVA) scheduled to receive a second cycle of cisplatin-based CCRT are stratified by CRT dose (<66 Gy vs ≥66 Gy) and randomized using a computer-generated sequence with block size 4 or 8, in a 1:1:1 ratio, to the FR group, the ta-VNS group, or the usual-care control group; the FR and ta-VNS groups are further randomized to true or sham subgroups. The foot reflexology intervention is delivered twice weekly for 20 minutes over two weeks and comprises a relaxation phase, a head-neck/gastrointestinal regulation phase, and a circulation/detoxification phase; the sham condition applies light, non-specific touch. The ta-VNS intervention stimulates the left tragus, cymba conchae, and cavum conchae (pulse width 250 µs, 25 Hz, 0.5-5 mA individualized to a tingling sensation, 30 s on/off) twice weekly for 20 minutes over two weeks; the sham condition stimulates the left earlobe at 0.5 mA. Auricular acupressure with magnetic beads is self-administered three times daily. Outcomes are assessed at T0 (baseline), T1 (week 1), T2 (week 2), and T3 (week 4). Data are analyzed with generalized estimating equation (GEE) models.

Inclusion criteria

• Pathologically confirmed head and neck cancer, clinical stage II-IVA, age 30-75 years, conscious, able to communicate and comprehend, and able to comply with study procedures
• Scheduled to receive a second cycle of cisplatin-based concurrent chemoradiotherapy
• ECOG performance status ≤2

Exclusion criteria

• Severe cognitive impairment or psychiatric illness precluding comprehension or cooperation
• Open wounds or skin lesions of the foot or ear, lower-limb edema, history of deep vein thrombosis, or diabetes with most recent HbA1c >7.5%
• Cardiac pacemaker or other implanted electronic device, or other severe cardiovascular disease
• Severe bone-marrow suppression (WBC <2,000/µL or platelets <50,000/µL)
• Pregnant or breastfeeding women
• History of epilepsy or seizures
• Physically frail condition