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

23. juli 2026 opdateret af: Chun Hou Huang, Tzu Chi University

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

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.

Studieoversigt

Detaljeret beskrivelse

This is a three-arm parallel, repeated-measures randomized controlled trial conducted in the otolaryngology outpatient and inpatient settings of Hualien Tzu Chi Hospital. Eligible patients with pathologically confirmed HNC (clinical stage II-IVA) scheduled to receive a second cycle of cisplatin-based CCRT are stratified by CRT dose (<66 Gy vs ≥66 Gy) and randomized using a computer-generated sequence with block size 4 or 8, in a 1:1:1 ratio, to the FR group, the ta-VNS group, or the usual-care control group; the FR and ta-VNS groups are further randomized to true or sham subgroups. The foot reflexology intervention is delivered twice weekly for 20 minutes over two weeks and comprises a relaxation phase, a head-neck/gastrointestinal regulation phase, and a circulation/detoxification phase; the sham condition applies light, non-specific touch. The ta-VNS intervention stimulates the left tragus, cymba conchae, and cavum conchae (pulse width 250 µs, 25 Hz, 0.5-5 mA individualized to a tingling sensation, 30 s on/off) twice weekly for 20 minutes over two weeks; the sham condition stimulates the left earlobe at 0.5 mA. Auricular acupressure with magnetic beads is self-administered three times daily. Outcomes are assessed at T0 (baseline), T1 (week 1), T2 (week 2), and T3 (week 4). Data are analyzed with generalized estimating equation (GEE) models.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

      • Hualien City, Taiwan, 970
        • Rekruttering
        • Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
        • Kontakt:

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

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Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A: Foot Reflexology - True (n=36)
Procedure: True Foot Reflexology
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).
Sham-komparator: Arm B: Foot Reflexology - Sham (n=36)
Procedure: Sham Foot Reflexology
Light touch on non-specific foot areas without
Eksperimentel: Arm C: ta-VNS - True (n=36)
Device: True ta-VNS + Procedure: Auricular Acupressure
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.
Magnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; 3×/day, ~30 s per point; changed every 2-3 days.
Sham-komparator: Arm D: ta-VNS - Sham (n=36)
Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure
Beads at left earlobe (non-vagal regions), same frequency/duration.
Left earlobe, 0.5 mA, otherwise identical parameters.
Aktiv komparator: Arm E: Usual Care (n=36)
Other: Usual Care
Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Numeric Rating Scale (NRS) for pain
Tidsramme: T0 baseline, T1 week 1, T2 week 2, T3 week 4
0-10 scale; 0 = no pain, 10 = worst pain.
T0 baseline, T1 week 1, T2 week 2, T3 week 4

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. juli 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

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