Head and Neck NeoplasmsNCT07711626
Foot Reflexology and Ta-VNS for Symptom Management in Head and Neck Cancer During CCRT
A study testing True Foot Reflexology, True ta-VNS and True Auricular Acupressure in people with Head and Neck Neoplasms and Xerostomia, run by Tzu Chi University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Head and Neck Neoplasms, Xerostomia, Cancer-related Fatigue
- What is being tested?
- True Foot Reflexology, True ta-VNS and True Auricular Acupressure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chun-Hou Huang contact
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
Hualien City, 970
Yu-Fu Chou Chou, MD, 886-3-8561825, yufuchou@yahoo.com.tw
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Head and Neck Neoplasms, Xerostomia, Cancer-related Fatigue, Pain
- Being tested
- True Foot Reflexology, Sham Foot Reflexology, True ta-VNS, Sham ta-VNS, True Auricular Acupressure
- Keywords
- Foot Reflexology, Transcutaneous Auricular Vagus Nerve Stimulation, ta-VNS, Auricular Acupressure, Head and Neck Cancer, Concurrent Chemoradiotherapy, Xerostomia, Cancer-Related Fatigue, Pain, Sleep Quality
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True Foot ReflexologyProcedure or surgery
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 Foot ReflexologyProcedure or surgery
Light touch on non-specific foot areas without
True ta-VNSDevice
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.
Sham ta-VNSDevice
Left earlobe, 0.5 mA, otherwise identical parameters.
True Auricular AcupressureProcedure or surgery
Magnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; 3×/day, ~30 s per point; changed every 2-3 days.
Sham Auricular AcupressureProcedure or surgery
Beads at left earlobe (non-vagal regions), same frequency/duration.
Usual CareOther
Standard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Foot Reflexology - True (n=36) | Experimental | Procedure: True Foot Reflexology Receives: Procedure: True Foot Reflexology |
| Arm B: Foot Reflexology - Sham (n=36) | Sham comparator | Procedure: Sham Foot Reflexology Receives: Procedure: Sham Foot Reflexology |
| Arm C: ta-VNS - True (n=36) | Experimental | Device: True ta-VNS + Procedure: Auricular Acupressure Receives: Device: True ta-VNS; Procedure: True Auricular Acupressure |
| Arm D: ta-VNS - Sham (n=36) | Sham comparator | Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure Receives: Device: Sham ta-VNS; Procedure: Sham Auricular Acupressure |
| Arm E: Usual Care (n=36) | Active comparator | Other: Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Rating Scale (NRS) for pain
0-10 scale; 0 = no pain, 10 = worst pain.
Measured: T0 baseline, T1 week 1, T2 week 2, T3 week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start13 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tzu Chi University
- Sponsor type
- University, hospital or other
- Collaborators
- Hualien Tzu Chi General Hospital
- Responsible party
- Principal investigator, Chun Hou Huang, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711626
- Sponsor's protocol ID
- TCU-CHHuang-FRtaVNS-HNC-2026
- Other IDs
- IRB114-189-A
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11395238Chou 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.
PubMed 35528798Zuo 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.
PubMed 37730386Mirabile 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.
PubMed 26712589
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07711626
- Acronym / sponsor ID
- TCU-CHHuang-FRtaVNS-HNC-2026
- Conditions
- Head and Neck Neoplasms, Xerostomia, Cancer-related Fatigue, Pain
- Keywords
- Foot Reflexology, Transcutaneous Auricular Vagus Nerve Stimulation, ta-VNS, Auricular Acupressure, Head and Neck Cancer, Concurrent Chemoradiotherapy, Xerostomia, Cancer-Related Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tzu Chi UniversityUniversity, hospital or other
- Collaborators
- Hualien Tzu Chi General Hospital
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A: Foot Reflexology - True (n=36) | Experimental | Procedure: True Foot ReflexologyProcedure: True Foot Reflexology |
| Arm B: Foot Reflexology - Sham (n=36) | Sham comparator | Procedure: Sham Foot ReflexologyProcedure: Sham Foot Reflexology |
| Arm C: ta-VNS - True (n=36) | Experimental | Device: True ta-VNS, Procedure: True Auricular AcupressureDevice: True ta-VNS + Procedure: Auricular Acupressure |
| Arm D: ta-VNS - Sham (n=36) | Sham comparator | Device: Sham ta-VNS, Procedure: Sham Auricular AcupressureDevice: Sham ta-VNS + Procedure: Sham Auricular Acupressure |
| Arm E: Usual Care (n=36) | Active comparator | Other: Usual CareOther: Usual Care |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True Foot ReflexologyTwice 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). | Procedure or surgery | Arm A: Foot Reflexology - True (n=36) |
| Sham Foot ReflexologyLight touch on non-specific foot areas without | Procedure or surgery | Arm B: Foot Reflexology - Sham (n=36) |
| True ta-VNSLeft 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. | Device | Arm C: ta-VNS - True (n=36) |
| Sham ta-VNSLeft earlobe, 0.5 mA, otherwise identical parameters. | Device | Arm D: ta-VNS - Sham (n=36) |
| True Auricular AcupressureMagnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; 3×/day, ~30 s per point; changed every 2-3 days. | Procedure or surgery | Arm C: ta-VNS - True (n=36) |
| Sham Auricular AcupressureBeads at left earlobe (non-vagal regions), same frequency/duration. | Procedure or surgery | Arm D: ta-VNS - Sham (n=36) |
| Usual CareStandard CCRT nursing care, antiemetic medication, side-effect prevention education, and symptom monitoring; no study intervention. | Other | Arm E: Usual Care (n=36) |
Primary outcome
Change in Numeric Rating Scale (NRS) for pain
Time frame: T0 baseline, T1 week 1, T2 week 2, T3 week 4
0-10 scale; 0 = no pain, 10 = worst pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Results publication: PubMed 11395238Eisbruch 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.
- Results publication: PubMed 35528798Chou 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.
- Results publication: PubMed 37730386Zuo 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.
- Results publication: PubMed 26712589Mirabile 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun-Hou Huang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True Foot Reflexology, True ta-VNS and True Auricular Acupressure in people with Head and Neck Neoplasms and Xerostomia, run by Tzu Chi University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Fu Chou MD (886-3-8561825, yufuchou@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Rating Scale (NRS) for pain (time frame: T0 baseline, T1 week 1, T2 week 2, T3 week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07711626, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.