Trial Title:
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related Neuropathic Pain
NCT ID:
NCT05543239
Condition:
Neuropathic Pain
Radiotherapy Side Effect
Conditions: Official terms:
Neuralgia
Conditions: Keywords:
Radiotherapy-Related Neuropathic Pain
Transcutaneous Auricular Vagus Nerve Stimulation
Head and Neck Cancers
Randomized controlled trials
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
An independent physiotherapist performs vagus nerve stimulation or sham stimulation
according to the group envelope; Investigators (physicians) are only responsible for
administering medications other than vagus nerve stimulation;Before treatment, all
subjects were told that the intensity of this treatment method may not be felt; The
therapeutic device is placed in an opaque airtight pouch that is invisible to both the
clinician and the patient during use. The control strategy used "transient sham
stimulation", which allows for subjects blinding while delivering a true placebo
treatment. Data analysts will be blinded to the allocated treatment group.
Intervention:
Intervention type:
Device
Intervention name:
Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS)
Description:
Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) works by stimulating the
auricular branches of the vagus nerve (mainly distributed in the concha cavity and
conchae) through electrical impulses.Electrodes were placed on the concha of the left ear
after cleaning the skin of the concha with a small disposable alcohol pad. Stimulation
pulses (frequency 30 Hz, pulse width 300 us) were generated by TaVNS device, the
amplitude was increased within 30 seconds to the subject produced a tingling sensation,
and then descend within 15 seconds to the maximum tolerable amount without pain. Inform
the subject that "target stimulus has been reached", then stimulate for 30 minutes.
Arm group label:
TaVNS
Intervention type:
Device
Intervention name:
Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS)
Description:
Place electrodes on the concha of the left ear after cleaning the skin of the concha with
a small disposable alcohol pad. The same stimulation pulses (30 Hz frequency, 300 us
pulse width) were generated by the same device, the amplitude was increased within 30
seconds to the subject produced a tingling sensation, and then ramps down to zero
stimulus over 15 seconds. The subjects were told that "the target stimulus has been
reached". Patients receive sham stimulation for 30minutes.
Arm group label:
Sham TaVNS
Summary:
This multi-center, randomized, double-blind, sham-controlled trial aims to investigate
the effect and safety of TaVNS in treating radiotherapy-related neuropathic pain.
Detailed description:
Radiotherapy-related neuropathic pain(RRNP) is one of the most distressing complications
after radiotherapy for head and neck cancers. The prevalence of neuropathic pain in
cancer pain patients is as high as 31-45%.Our previous RCT of pregabalin for RRNP showed
that nearly 41.6% of patients still did not achieve 30% pain relief even with standard
doses of pregabalin. At the same time, drug side effects such as dizziness and obesity
are common, and a dose titration process for at least one week is required.Therefore, new
treatments that effectively relieve pain and improve quality of life must be explored.
Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) works by stimulating the
auricular branches of the vagus nerve through electrical impulses. Previous studies have
shown it can relieve various pains including migraine, cluster headache, musculoskeletal
pain with few adverse events. This study plans to evaluate the efficacy of TaVNS versus
sham stimulation for relieving RRNP, and assessed its safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female patients aged ≥18 years with an estimated survival of at least 5
months;
2. Prior radiotherapy for histologically confirmed cancer ≥ 6 months prior to study
entry;
3. Pain for at least 4 weeks with an average intensity of ≥ 4 on an 11-point numeric
rating scale (NRS) in the run-in period, and pain locations in accordance with
radiated innervated areas, e.g. head, face, neck and arms;
4. Neuropathic pain defined according to clinical history, symptoms, physical signs,
and a score ≥ 12 in the Chinese version of Leeds Assessment of Neuropathic Symptoms
and Signs questionnaire (LANSS) by two trained and experienced neurology
specialists.
Exclusion Criteria:
1. Current diagnosis of tumor recurrence or metastasis and evidence of tumor-associated
pain;
2. Patients with non-radiotherapy induced neuropathic pain, e.g. postherpetic
neuralgia, diabetes mellitus, HIV infection, spinal cord injury and other
neurological disease;
3. Use of carbamazepine, gabapentin, pregabalin, TaVNS or transcranial magnetic
stimulation within the last 30 days prior to study entry;
4. Other ongoing treatment for neuropathic pain, including antidepressants with
norepinephrine and serotonin reuptake inhibition, calcium channel α2-δ ligands and
other anticonvulsant medications, and topical lidocaine;
5. Concomitant medication that may cause an adverse interaction with pregabalin,
including sedative (e.g., benzodiazepines);
6. Significant renal impairment: plasma creatinine>1.5mg/ml, creatinine clearance < 60
mL/min;
7. History of anaphylactic response to pregabalin;
8. Ulceration of the auricle skin; Diagnosis of mental illness, peptic ulcer,AV III
degree block, heart rate< 50/min, heart rate corrected QT interval > 450ms;
9. Patients with cardiac pacemakers or implanted ECG monitoring equipment;
10. Evidence of severe systemic diseases;
11. Subjects with any other condition which, in the investigator's judgment might
interfere the outcome of the study;
12. Refuse to provide written informed consent;
13. Cognitive function and language skills are insufficient to complete study
questionnaires;
14. Pregnant or lactating women.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Yamei Tang, M.D., PhD.
Facility:
Name:
Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qiuyan Chen
Facility:
Name:
Department of Nasopharyngeal Carcinoma, The Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dongping Chen
Facility:
Name:
Department of Neurology, The Affiliated Brain Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510450
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dong Zheng
Start date:
September 16, 2022
Completion date:
March 1, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05543239
