- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07711626
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
Status
Rekruttering
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
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yu-Fu Chou MD
- Telefonnummer: 886-3-8561825
- E-mail: yufuchou@yahoo.com.tw
Undersøgelse Kontakt Backup
- Navn: Chun-Hou Huang
- E-mail: hou2017@gms.tcu.edu.tw
Studiesteder
-
-
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Hualien City, Taiwan, 970
- Rekruttering
- Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
-
Kontakt:
- Yu-Fu Chou Chou, MD
- Telefonnummer: 886-3-8561825
- E-mail: yufuchou@yahoo.com.tw
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
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|
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.
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Sham-komparator: Arm D: ta-VNS - Sham (n=36)
Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure
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Beads at left earlobe (non-vagal regions), same frequency/duration.
Left earlobe, 0.5 mA, otherwise identical parameters.
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Aktiv komparator: Arm E: Usual Care (n=36)
Other: Usual Care
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Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.
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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
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0-10 scale; 0 = no pain, 10 = worst pain.
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T0 baseline, T1 week 1, T2 week 2, T3 week 4
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):695-704. doi: 10.1016/s0360-3016(01)01512-7.
- Chou YH, Yeh ML, Huang TS, Hsu H. Acupoint stimulation improves pain and quality of life in head and neck cancer patients with chemoradiotherapy: A randomized controlled trial. Asia Pac J Oncol Nurs. 2021 Dec 25;9(1):61-68. doi: 10.1016/j.apjon.2021.11.002. eCollection 2022 Jan.
- Zuo X, Li Y, Rong X, Yang X, Zhu Y, Pan D, Li H, Shen QY, Tang Y. Efficacy of transcutaneous auricular vagus nerve stimulation on radiotherapy-related neuropathic pain in patients with head and neck cancers (RELAX): protocol for a multicentre, randomised, double-blind, sham-controlled trial. BMJ Open. 2023 Sep 20;13(9):e072724. doi: 10.1136/bmjopen-2023-072724.
- Mirabile A, Airoldi M, Ripamonti C, Bolner A, Murphy B, Russi E, Numico G, Licitra L, Bossi P. Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. Crit Rev Oncol Hematol. 2016 Mar;99:100-6. doi: 10.1016/j.critrevonc.2015.11.010. Epub 2015 Dec 3.
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
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Mundsygdomme
- Stomatognatiske sygdomme
- Sygdomme i nervesystemet
- Psykiske lidelser
- Neoplasmer efter sted
- Neoplasmer
- Søvnvågningsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Spytkirtelsygdomme
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerte
- Søvninitiering og vedligeholdelsesforstyrrelser
- Neoplasmer i hoved og hals
- Xerostomi
Andre undersøgelses-id-numre
- TCU-CHHuang-FRtaVNS-HNC-2026
- IRB114-189-A (Anden identifikator: Research Ethics Committee, Hualien Tzu Chi Hospital)
Plan for individuelle deltagerdata (IPD)
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