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Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy

Primary Purpose

CIPN, Chemotherapy-induced Peripheral Neuropathy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vagus nerve stimulation
sham vagus nerve stimulation
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CIPN

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is currently receiving chemotherapy drugs with neurotoxicity
  2. New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms

Exclusion Criteria:

  1. Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation.
  2. Patients taking analgesics due to pain in other parts of the body.

Sites / Locations

  • People's Hospital of Peking University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sham stimulation group

stimulation group

Arm Description

Outcomes

Primary Outcome Measures

NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.
NRS(numerical rating scale)
0-10，0 =no pain, 10 = the most severe pain.

Secondary Outcome Measures

NCI-CTC v4.0 neurotoxicity classification
Assess the degree of motor neurotoxicity and sensory neurotoxicity
QST( Quantitative Sensory Testing)
left finger, thermal thretshold,thermal pain threshold,cold threshold,cold pain threshold,
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
Athens insomnia scale
<4 No sleep disorder,4-6=Suspicious insomnia,>6=Insomnia
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

Full Information

First Posted
June 8, 2022
Last Updated
June 26, 2022
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05434403
Brief Title
Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy
Official Title
Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CIPN, Chemotherapy-induced Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham stimulation group
Arm Type
Placebo Comparator
Arm Title
stimulation group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vagus nerve stimulation
Intervention Description
vagus nerve electrical stimulation through ear skin
Intervention Type
Device
Intervention Name(s)
sham vagus nerve stimulation
Intervention Description
sham vagus nerve electrical stimulation through ear skin
Primary Outcome Measure Information:
Title
NRS(numerical rating scale)
Description
0-10，0 =no pain, 10 = the most severe pain.
Time Frame
Day0
Title
NRS(numerical rating scale)
Description
0-10，0 =no pain, 10 = the most severe pain.
Time Frame
Day3
Title
NRS(numerical rating scale)
Description
0-10，0 =no pain, 10 = the most severe pain.
Time Frame
Day5
Title
NRS(numerical rating scale)
Description
0-10，0 =no pain, 10 = the most severe pain.
Time Frame
Day8
Title
NRS(numerical rating scale)
Description
0-10，0 =no pain, 10 = the most severe pain.
Time Frame
Day14
Title
NRS(numerical rating scale)
Description
0-10，0 =no pain, 10 = the most severe pain.
Time Frame
Day30
Title
NRS(numerical rating scale)
Description
0-10，0 =no pain, 10 = the most severe pain.
Time Frame
Day60
Title
NRS(numerical rating scale)
Description
0-10，0 =no pain, 10 = the most severe pain.
Time Frame
Day90
Secondary Outcome Measure Information:
Title
NCI-CTC v4.0 neurotoxicity classification
Description
Assess the degree of motor neurotoxicity and sensory neurotoxicity
Time Frame
Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90
Title
QST( Quantitative Sensory Testing)
Description
left finger, thermal thretshold,thermal pain threshold,cold threshold,cold pain threshold,
Time Frame
Day1,Day14
Title
IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α
Description
Hematological examination to test the concentration of IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α
Time Frame
Day1,Day14
Title
Athens insomnia scale
Description
<4 No sleep disorder,4-6=Suspicious insomnia,>6=Insomnia
Time Frame
Day1,Day8,Day14,Day30,Day60,Day90
Title
SF-12，Short From health survey -12
Description
Calculate the Physical Component Summary (PCS) and Mental Component Summary (MCS).The higher the score, the worse the quality of life
Time Frame
Day1,Day8,Day14,Day30,Day60,Day90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Feng, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
People's Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy

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