NCT05434403

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 8, 2022

Last Update Submit

June 26, 2022

Conditions

CIPNChemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (8)

  • NRS(numerical rating scale)

    0-10，0 =no pain, 10 = the most severe pain.

    Day0

  • NRS(numerical rating scale)

    0-10，0 =no pain, 10 = the most severe pain.

    Day3

  • NRS(numerical rating scale)

    0-10，0 =no pain, 10 = the most severe pain.

    Day5

  • NRS(numerical rating scale)

    0-10，0 =no pain, 10 = the most severe pain.

    Day8

  • NRS(numerical rating scale)

    0-10，0 =no pain, 10 = the most severe pain.

    Day14

  • NRS(numerical rating scale)

    0-10，0 =no pain, 10 = the most severe pain.

    Day30

  • NRS(numerical rating scale)

    0-10，0 =no pain, 10 = the most severe pain.

    Day60

  • NRS(numerical rating scale)

    0-10，0 =no pain, 10 = the most severe pain.

    Day90

Secondary Outcomes (5)

  • NCI-CTC v4.0 neurotoxicity classification

    Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90

  • QST( Quantitative Sensory Testing)

    Day1,Day14

  • IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α

    Day1,Day14

  • Athens insomnia scale

    Day1,Day8,Day14,Day30,Day60,Day90

  • SF-12，Short From health survey -12

    Day1,Day8,Day14,Day30,Day60,Day90

Study Arms (2)

Sham stimulation group

PLACEBO COMPARATOR
Device: sham vagus nerve stimulation

stimulation group

EXPERIMENTAL
Device: Vagus nerve stimulation

Interventions

Vagus nerve stimulationDEVICE

vagus nerve electrical stimulation through ear skin

stimulation group
sham vagus nerve stimulationDEVICE

sham vagus nerve electrical stimulation through ear skin

Sham stimulation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

Vagus Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Yi Feng, MD

    Peking University People's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of department of Anesthesiology and Pain medicine

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 28, 2022

Study Start

June 2, 2022

Primary Completion

August 1, 2022

Study Completion

November 1, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)