Foot Reflexology and Ta-VNS for Symptom Management in Head and Neck Cancer During CCRT
NCT07711626
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
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
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NCT07711626