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

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.

Conditions

• Head and Neck Neoplasms
• Xerostomia
• Cancer-related Fatigue
• Pain

Interventions

PROCEDURE

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).

PROCEDURE

Sham Foot Reflexology

Light touch on non-specific foot areas without

DEVICE

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.

DEVICE

Sham ta-VNS

Left earlobe, 0.5 mA, otherwise identical parameters.

PROCEDURE

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.

PROCEDURE

Sham Auricular Acupressure

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

OTHER

Usual Care

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

Sponsors & Collaborators

• Hualien Tzu Chi General Hospital

  collaborator OTHER

• Tzu Chi University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-13

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Taiwan

Study Locations