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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorTzu Chi University

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • True Foot Reflexology
  • Sham Foot Reflexology
  • True ta-VNS
  • Sham ta-VNS
  • True Auricular Acupressure
  • Sham Auricular Acupressure
  • Usual Care

Treatment groups

180 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Tzu Chi University

Lead sponsor

Hualien Tzu Chi General Hospital

Collaborator