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Recruiting NCT07711626

NCT07711626 Foot Reflexology and Ta-VNS for Symptom Management in Head and Neck Cancer During CCRT

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Clinical Trial Summary
NCT ID NCT07711626
Status Recruiting
Phase —
Sponsor Tzu Chi University
Condition Head and Neck Neoplasms
Study Type INTERVENTIONAL
Enrollment 180 participants
Start Date 2026-07-13
Primary Completion 2028-12-31

Eligibility & Interventions

Sex All sexes
Min Age 30 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
True Foot ReflexologySham Foot ReflexologyTrue ta-VNS

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 180 participants in total. It began in 2026-07-13 with a primary completion date of 2028-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Yu-Fu Chou MD

✉ yufuchou@yahoo.com.tw

📞 886-3-8561825

Frequently Asked Questions

Who can join the NCT07711626 clinical trial?

This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Head and Neck Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07711626 currently recruiting?

Yes, NCT07711626 is actively recruiting participants. Contact the research team at yufuchou@yahoo.com.tw for enrollment information.

Where is the NCT07711626 trial being conducted?

This trial is being conducted at Hualien City, Taiwan.

Who is sponsoring the NCT07711626 clinical trial?

NCT07711626 is sponsored by Tzu Chi University. The trial plans to enroll 180 participants.

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