CIPNNCT05434403
Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy
A study testing Vagus nerve stimulation in people with CIPN and Chemotherapy-induced Peripheral Neuropathy, run by Peking University People's Hospital at 1 site in China.
Trial summary
Chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. Nowaday, CIPN is mainly treated with drugs, but the therapeutic effect is not satisfactory. Previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CIPN, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is currently receiving chemotherapy drugs with neurotoxicity
- New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms
Who cannot join
- Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation.
- Patients taking analgesics due to pain in other parts of the body.
Trial locations and contacts
1 site in 1 country.
China1 site
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
About this study
Official title: Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Study
Chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. Nowaday, CIPN is mainly treated with drugs, but the therapeutic effect is not satisfactory. Previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. Vagus nerve stimulation can not only relieve pain by regulating the autonomic nervous system, but also participate in the immune response. Investigators hope that the treatment by vagus nerve electrical stimulation through ear skin can improve the pain and neurotoxicity scores of CIPN patient.If it is proved that vagus nerve stimulation can effectively treat CIPN, it will become a simple and safe non-drug treatment which has good application prospects.
- Conditions
- CIPN, Chemotherapy-induced Peripheral Neuropathy
- Being tested
- Vagus nerve stimulation, sham vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulationDevice
vagus nerve electrical stimulation through ear skin
sham vagus nerve stimulationDevice
sham vagus nerve electrical stimulation through ear skin
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation group | Placebo comparator | Not described Receives: Device: sham vagus nerve stimulation |
| stimulation group | Experimental | Not described Receives: Device: Vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
Measured: Day0
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
Measured: Day3
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
Measured: Day5
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
Measured: Day8
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
Measured: Day14
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
Measured: Day30
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
Measured: Day60
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
Measured: Day90
Secondary outcomes (5)
NCI-CTC v4.0 neurotoxicity classification
Assess the degree of motor neurotoxicity and sensory neurotoxicity
Measured: Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90
QST( Quantitative Sensory Testing)
left finger, thermal thretshold,thermal pain threshold,cold threshold,cold pain threshold,
Measured: Day1,Day14
IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α
Hematological examination to test the concentration of IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α
Measured: Day1,Day14
Athens insomnia scale
<4 No sleep disorder,4-6=Suspicious insomnia,>6=Insomnia
Measured: Day1,Day8,Day14,Day30,Day60,Day90
SF-12，Short From health survey -12
Calculate the Physical Component Summary (PCS) and
Mental Component Summary (MCS).The higher the score, the worse the quality of life
Measured: Day1,Day8,Day14,Day30,Day60,Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start2 Jun 2022
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPNStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, MD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434403
- Sponsor's protocol ID
- 2022PHB107-001
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05434403
- Acronym / sponsor ID
- 2022PHB107-001
- Conditions
- CIPN, Chemotherapy-induced Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 28 Jun 2022 (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.
Chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. Nowaday, CIPN is mainly treated with drugs, but the therapeutic effect is not satisfactory. Previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. Vagus nerve stimulation can not only relieve pain by regulating the autonomic nervous system, but also participate in the immune response. Investigators hope that the treatment by vagus nerve electrical stimulation through ear skin can improve the pain and neurotoxicity scores of CIPN patient.If it is proved that vagus nerve stimulation can effectively treat CIPN, it will become a simple and safe non-drug treatment which has good application prospects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation group | Placebo comparator | Device: sham vagus nerve stimulation |
| stimulation group | Experimental | Device: Vagus nerve stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is currently receiving chemotherapy drugs with neurotoxicity
- New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms
Key exclusion criteria (2 listed)
- Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation.
- Patients taking analgesics due to pain in other parts of the body.
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 |
|---|---|---|
| Vagus nerve stimulationvagus nerve electrical stimulation through ear skin | Device | stimulation group |
| sham vagus nerve stimulationsham vagus nerve electrical stimulation through ear skin | Device | Sham stimulation group |
Primary outcome
NRS(numerical rating scale)
Time frame: Day0
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
Time frame: Day3
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
Time frame: Day5
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
Time frame: Day8
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
Time frame: Day14
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
Time frame: Day30
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
Time frame: Day60
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
Time frame: Day90
0-10，0 =no pain, 10 = the most severe pain.
5 secondary outcomes
NCI-CTC v4.0 neurotoxicity classification
Time frame: Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90
QST( Quantitative Sensory Testing)
Time frame: Day1,Day14
IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α
Time frame: Day1,Day14
Athens insomnia scale
Time frame: Day1,Day8,Day14,Day30,Day60,Day90
SF-12，Short From health survey -12
Time frame: Day1,Day8,Day14,Day30,Day60,Day90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- 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. This study is not recruiting at the moment.
Yi Feng, MD study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve stimulation in people with CIPN and Chemotherapy-induced Peripheral Neuropathy, run by Peking University People's Hospital at 1 site in China.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jun 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS(numerical rating scale) (time frame: Day0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2022.