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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
RECRUITING
Hualien City
Contact Information
Primary
Yu-Fu Chou MD
yufuchou@yahoo.com.tw
886-3-8561825
Backup
Chun-Hou Huang
hou2017@gms.tcu.edu.tw
Time Frame
Start Date: 2026-07-13
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 180
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Hualien Tzu Chi General Hospital
Leads: Tzu Chi University

This content was sourced from clinicaltrials.gov