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

Overview

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.

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.