Foot reflexology and ta-VNS for symptom relief in head and neck cancer during CCRT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind, sham-controlled study examines three passive or self-administered interventions—foot reflexology, ta-VNS, and auricular acupressure—vs. usual care in people with head and neck cancer undergoing a second cycle of cisplatin-based concurrent chemoradiotherapy. Participants are assigned to foot reflexology, ta-VNS (with true and sham subgroups), or a control group, and are evaluated at baseline, week 1, week 2, and week 4. Interventions involve a 20-minute session twice weekly for two weeks (with a sham touch for controls appropriately blinded), ta-VNS parameters set to tolerable tingling, and self-administered auricular acupressure beads. Outcomes will be analyzed using generalized estimating equations to assess changes over time in pain, xerostomia, fatigue, sleep disturbance, and related symptoms. The study is conducted at Hualien Tzu Chi Hospital with Tzu Chi University as lead sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Yu-Fu Chou MD
• Email: yufuchou@yahoo.com.tw
• Phone: 886-3-8561825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.