Cancer-related Fatigue, Head and Neck Neoplasms, Pain, Xerostomia
Conditions
Keywords
Foot Reflexology, Transcutaneous Auricular Vagus Nerve Stimulation, ta-VNS, Auricular Acupressure, Head and Neck Cancer, Concurrent Chemoradiotherapy, Xerostomia, Cancer-Related Fatigue, Pain, Sleep Quality
Brief 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.
Detailed description
This is a three-arm parallel, repeated-measures randomized controlled trial conducted in the otolaryngology outpatient and inpatient settings of Hualien Tzu Chi Hospital. Eligible patients with pathologically confirmed HNC (clinical stage II-IVA) scheduled to receive a second cycle of cisplatin-based CCRT are stratified by CRT dose (\<66 Gy vs ≥66 Gy) and randomized using a computer-generated sequence with block size 4 or 8, in a 1:1:1 ratio, to the FR group, the ta-VNS group, or the usual-care control group; the FR and ta-VNS groups are further randomized to true or sham subgroups. The foot reflexology intervention is delivered twice weekly for 20 minutes over two weeks and comprises a relaxation phase, a head-neck/gastrointestinal regulation phase, and a circulation/detoxification phase; the sham condition applies light, non-specific touch. The ta-VNS intervention stimulates the left tragus, cymba conchae, and cavum conchae (pulse width 250 µs, 25 Hz, 0.5-5 mA individualized to a tingling sensation, 30 s on/off) twice weekly for 20 minutes over two weeks; the sham condition stimulates the left earlobe at 0.5 mA. Auricular acupressure with magnetic beads is self-administered three times daily. Outcomes are assessed at T0 (baseline), T1 (week 1), T2 (week 2), and T3 (week 4). Data are analyzed with generalized estimating equation (GEE) models.
Interventions
PROCEDURETrue 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).
PROCEDURESham Foot Reflexology
Light touch on non-specific foot areas without
DEVICETrue 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.
DEVICESham ta-VNS
Left earlobe, 0.5 mA, otherwise identical parameters.
PROCEDURETrue 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.
PROCEDURESham Auricular Acupressure
Beads at left earlobe (non-vagal regions), same frequency/duration.
OTHERUsual Care
Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.
Sponsors
Tzu Chi University
Hualien Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Scale (NRS) for pain | T0 baseline, T1 week 1, T2 week 2, T3 week 4 | 0-10 scale; 0 = no pain, 10 = worst pain. |
Countries
Taiwan
Contacts
CONTACTYu-Fu Chou MD
CONTACTChun-Hou Huang
Outcome results
None listed