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

NCT07711626 | Recruiting

• 2 other identifiers: TCU-CHHuang-FRtaVNS-HNC-2026IRB114-189-A
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Scale (NRS) for pain

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

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

Study Arms (5)

Arm A: Foot Reflexology - True (n=36)

EXPERIMENTAL

Procedure: True Foot Reflexology

Procedure: True Foot Reflexology

Arm B: Foot Reflexology - Sham (n=36)

SHAM COMPARATOR

Procedure: Sham Foot Reflexology

Procedure: Sham Foot Reflexology

Arm C: ta-VNS - True (n=36)

EXPERIMENTAL

Device: True ta-VNS + Procedure: Auricular Acupressure

Device: True ta-VNS; Procedure: True Auricular Acupressure

Arm D: ta-VNS - Sham (n=36)

SHAM COMPARATOR

Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure

Device: Sham ta-VNS; Procedure: Sham Auricular Acupressure

Arm E: Usual Care (n=36)

ACTIVE COMPARATOR

Other: Usual Care

Other: Usual Care

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).

Arm A: Foot Reflexology - True (n=36)

Sham Foot Reflexology PROCEDURE

Light touch on non-specific foot areas without

Arm B: Foot Reflexology - Sham (n=36)

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.

Arm C: ta-VNS - True (n=36)

Sham ta-VNS DEVICE

Left earlobe, 0.5 mA, otherwise identical parameters.

Arm D: ta-VNS - Sham (n=36)

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.

Arm C: ta-VNS - True (n=36)

Usual Care OTHER

Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.

Arm E: Usual Care (n=36)

Sham Auricular Acupressure PROCEDURE

Beads at left earlobe (non-vagal regions), same frequency/duration.

Arm D: ta-VNS - Sham (n=36)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tzu Chi University: lead
• Hualien Tzu Chi General Hospital: collaborator

Study Sites (1)

Hualien Tzu Chi Hospital, Department of Otorhinolaryngology

Hualien City, 970, Taiwan

RECRUITING

Related Publications (4)

• Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):695-704. doi: 10.1016/s0360-3016(01)01512-7.

  PMID: 11395238 RESULT

• Chou YH, Yeh ML, Huang TS, Hsu H. Acupoint stimulation improves pain and quality of life in head and neck cancer patients with chemoradiotherapy: A randomized controlled trial. Asia Pac J Oncol Nurs. 2021 Dec 25;9(1):61-68. doi: 10.1016/j.apjon.2021.11.002. eCollection 2022 Jan.

  PMID: 35528798 RESULT

• Zuo X, Li Y, Rong X, Yang X, Zhu Y, Pan D, Li H, Shen QY, Tang Y. Efficacy of transcutaneous auricular vagus nerve stimulation on radiotherapy-related neuropathic pain in patients with head and neck cancers (RELAX): protocol for a multicentre, randomised, double-blind, sham-controlled trial. BMJ Open. 2023 Sep 20;13(9):e072724. doi: 10.1136/bmjopen-2023-072724.

  PMID: 37730386 RESULT

• Mirabile A, Airoldi M, Ripamonti C, Bolner A, Murphy B, Russi E, Numico G, Licitra L, Bossi P. Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. Crit Rev Oncol Hematol. 2016 Mar;99:100-6. doi: 10.1016/j.critrevonc.2015.11.010. Epub 2015 Dec 3.

  PMID: 26712589 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yu-Fu Chou MD

CONTACT

886-3-8561825; yufuchou@yahoo.com.tw

Chun-Hou Huang

CONTACT

hou2017@gms.tcu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)