About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- True Foot Reflexology
- Sham Foot Reflexology
- True ta-VNS
- Sham ta-VNS
- True Auricular Acupressure
- Sham Auricular Acupressure
- Usual Care
Treatment groups
Sponsors and collaborators
Tzu Chi University
Lead sponsor
Hualien Tzu Chi General Hospital
Collaborator