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| ID | Type | Description | Link |
|---|---|---|---|
| IRB114-189-A | Other Identifier | Research Ethics Committee, Hualien Tzu Chi Hospital |
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| Name | Class |
|---|---|
| Buddhist Tzu Chi Medical Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Foot Reflexology - True (n=36) | Experimental | Procedure: True Foot Reflexology |
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| Arm B: Foot Reflexology - Sham (n=36) | Sham Comparator | Procedure: Sham Foot Reflexology |
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| Arm C: ta-VNS - True (n=36) | Experimental | Device: True ta-VNS + Procedure: Auricular Acupressure |
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| Arm D: ta-VNS - Sham (n=36) | Sham Comparator | Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure |
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| Arm E: Usual Care (n=36) | Active Comparator | Other: Usual Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| True Foot Reflexology | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Rating Scale (NRS) for pain | 0-10 scale; 0 = no pain, 10 = worst pain. | T0 baseline, T1 week 1, T2 week 2, T3 week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Fu Chou MD | Contact | 886-3-8561825 | yufuchou@yahoo.com.tw | |
| Chun-Hou Huang | Contact | hou2017@gms.tcu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hualien Tzu Chi Hospital, Department of Otorhinolaryngology | Recruiting | Hualien City | 970 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11395238 | Result | 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. | |
| 35528798 | Result | 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. |
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| Sham Foot Reflexology | Procedure | Light touch on non-specific foot areas without |
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| True ta-VNS | Device | 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. |
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| Sham ta-VNS | Device | Left earlobe, 0.5 mA, otherwise identical parameters. |
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| True Auricular Acupressure | Procedure | 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 Auricular Acupressure | Procedure | Beads at left earlobe (non-vagal regions), same frequency/duration. |
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| Usual Care | Other | Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention. |
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| 37730386 | Result | 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. |
| 26712589 | Result | 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. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D014987 | Xerostomia |
| D010146 | Pain |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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