RecruitingNot ApplicableNCT07711626

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

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

Sponsor

Tzu Chi University

Enrollment

180 participants

Start Date

Jul 13, 2026

Study Type

INTERVENTIONAL

Conditions

Pain Head and Neck Neoplasms Cancer-related Fatigue Xerostomia

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.

Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Sham Auricular Acupressure, a procedure called Sham Foot Reflexology, and others for people with chemoradiotherapy-related symptoms and head and neck neoplasms. The study is currently recruiting participants at 1 location. People eligible for this study include aged 30 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETrue 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).

PROCEDURESham Foot Reflexology

Light touch on non-specific foot areas without

DEVICETrue 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.

DEVICESham ta-VNS

Left earlobe, 0.5 mA, otherwise identical parameters.

PROCEDURETrue 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.

PROCEDURESham Auricular Acupressure

Beads at left earlobe (non-vagal regions), same frequency/duration.

OTHERUsual Care

Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.