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

ConditionsHead and Neck Neoplasms Xerostomia Cancer-related Fatigue Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30-75

SponsorTzu Chi University

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

True Foot Reflexology
Procedure/Surgery
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
Procedure/Surgery
Light touch on non-specific foot areas without
True ta-VNS
Device
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
Device
Left earlobe, 0.5 mA, otherwise identical parameters.
True Auricular Acupressure
Procedure/Surgery
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
Procedure/Surgery
Beads at left earlobe (non-vagal regions), same frequency/duration.
Usual Care
Other intervention
Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.

Treatment groups

180 Participants

are divided into 5 treatment groups

Group A: Arm A: Foot Reflexology - True (n=36)Experimental treatment 1 intervention

Group B: Arm B: Foot Reflexology - Sham (n=36)Sham comparator 1 intervention

Group C: Arm C: ta-VNS - True (n=36)Experimental treatment 2 interventions

Group D: Arm D: ta-VNS - Sham (n=36)Sham comparator 2 interventions

Group E: Arm E: Usual Care (n=36)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Numeric Rating Scale (NRS) for pain

0-10 scale; 0 = no pain, 10 = worst pain.

Time frame

T0 baseline, T1 week 1, T2 week 2, T3 week 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tzu Chi University

Lead sponsor

Hualien Tzu Chi General Hospital

Collaborator

Source ClinicalTrials.gov

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