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

RECRUITINGN/ASponsored by Tzu Chi University
Actively Recruiting
PhaseN/A
SponsorTzu Chi University
Started2026-07-13
Est. completion2028-12-31
Eligibility
Age30 Years – 75 Years
Healthy vol.Accepted

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

Age: 30 Years – 75 YearsHealthy volunteers accepted
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

Conditions5

CancerCancer-Related FatigueHead and Neck NeoplasmsPainXerostomia

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