Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related N… (NCT05543239) | Clinical Trial Compass
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Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related Neuropathic Pain
China116 participantsStarted 2022-09-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged ≥18 years with an estimated survival of at least 5 months;
✓. Prior radiotherapy for histologically confirmed cancer ≥ 6 months prior to study entry;
✓. 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;
✓. 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
✕. Current diagnosis of tumor recurrence or metastasis and evidence of tumor-associated pain;
✕. Patients with non-radiotherapy induced neuropathic pain, e.g. postherpetic neuralgia, diabetes mellitus, HIV infection, spinal cord injury and other neurological disease;
✕. Use of carbamazepine, gabapentin, pregabalin, TaVNS or transcranial magnetic stimulation within the last 30 days prior to study entry;
✕. 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;
✕. Concomitant medication that may cause an adverse interaction with pregabalin, including sedative (e.g., benzodiazepines);
✕
What they're measuring
1
Change from baseline to day 7 with respect to pain intensity based on the NRS.
Timeframe: Day 7
Trial details
NCT IDNCT05543239
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University