Clinical trial · Interventional
Foot Reflexology and Ta-VNS for Symptom Management in Head and Neck Cancer During CCRT
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pain | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham Auricular Acupressure | Procedure | — | UNRESOLVED |
| Sham Foot Reflexology | Procedure | — | UNRESOLVED |
| Sham ta-VNS | Device | — | UNRESOLVED |
| True Auricular Acupressure | Procedure | — | UNRESOLVED |
| True Foot Reflexology | Procedure | — | UNRESOLVED |
| True ta-VNS | Device | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm A: Foot Reflexology - True (n=36)
- description
- Procedure: True Foot Reflexology
- interventionNames
- Procedure: True Foot Reflexology
- type
- SHAM_COMPARATOR
- label
- Arm B: Foot Reflexology - Sham (n=36)
- description
- Procedure: Sham Foot Reflexology
- interventionNames
- Procedure: Sham Foot Reflexology
- type
- EXPERIMENTAL
- label
- Arm C: ta-VNS - True (n=36)
- description
- Device: True ta-VNS + Procedure: Auricular Acupressure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTEisbruch 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. PMID 11395238
- RESULTChou 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. PMID 35528798
- RESULTZuo 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. PMID 37730386
- RESULTMirabile 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. PMID 26712589