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

Sponsor
Tzu Chi University
Study ID
NCT07711626
Status
Recruiting
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Conditions

  • Cancer-related Fatigue
  • Head and Neck Neoplasms
  • Pain
  • Xerostomia

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • True Foot Reflexology — PROCEDURE
    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
    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
    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
    Beads at left earlobe (non-vagal regions), same frequency/duration.
  • Usual Care — OTHER
    Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Jul 13, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm A: Foot Reflexology - True (n=36)
    Procedure: True Foot Reflexology
  • Sham Comparator: Arm B: Foot Reflexology - Sham (n=36)
    Procedure: Sham Foot Reflexology
  • Experimental: Arm C: ta-VNS - True (n=36)
    Device: True ta-VNS + Procedure: Auricular Acupressure
  • Sham Comparator: Arm D: ta-VNS - Sham (n=36)
    Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure
  • Active Comparator: Arm E: Usual Care (n=36)
    Other: Usual Care

Primary Outcome Measure

Change in Numeric Rating Scale (NRS) for pain [ Time Frame: T0 baseline, T1 week 1, T2 week 2, T3 week 4 ]

Central Contacts

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