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

July 13, 2026 updated by: Chun Hou Huang, Tzu Chi University

Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Pain, Xerostomia, Fatigue, Sleep, and Treatment-Related Symptoms in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy: A Randomized, Single-Blind, Sham-Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Hualien City, Taiwan, 970
        • Recruiting
        • Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Foot Reflexology - True (n=36)
Procedure: True Foot Reflexology
Procedure: True 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).
Sham Comparator: Arm B: Foot Reflexology - Sham (n=36)
Procedure: Sham Foot Reflexology
Procedure: Sham Foot Reflexology
Light touch on non-specific foot areas without
Experimental: Arm C: ta-VNS - True (n=36)
Device: True ta-VNS + Procedure: Auricular Acupressure
Device: True 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.
Procedure: True 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.
Sham Comparator: Arm D: ta-VNS - Sham (n=36)
Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure
Procedure: Sham Auricular Acupressure
Beads at left earlobe (non-vagal regions), same frequency/duration.
Device: Sham ta-VNS
Left earlobe, 0.5 mA, otherwise identical parameters.
Active Comparator: Arm E: Usual Care (n=36)
Other: Usual Care
Other: Usual Care
Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numeric Rating Scale (NRS) for pain
Time Frame: T0 baseline, T1 week 1, T2 week 2, T3 week 4
0-10 scale; 0 = no pain, 10 = worst pain.
T0 baseline, T1 week 1, T2 week 2, T3 week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tzu Chi University

Collaborators

Buddhist Tzu Chi Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCU-CHHuang-FRtaVNS-HNC-2026
  • IRB114-189-A (Other Identifier: Research Ethics Committee, Hualien Tzu Chi Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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