Clinical Trials in Taiwan / NCT07711626
Recruiting Not applicable

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

NCT07711626 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2026-07-13
Last updated
2026-07-24

Condition(s) studied

Head and Neck NeoplasmsXerostomiaCancer-related FatiguePain

Investigational drug(s) / intervention(s)

True Foot ReflexologySham Foot ReflexologyTrue ta-VNSSham ta-VNSTrue Auricular AcupressureSham Auricular AcupressureUsual Care

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.

Study 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

Sex
ALL
Min age
30 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hualien Tzu Chi Hospital, Department of Otorhinolaryngology Hualien City Taiwan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07711626 on ClinicalTrials.gov ↗ ← All trials in Taiwan