Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients
Condition: Breast Cancer; Cancer, Therapy-Related; Cancer-related Fatigue; Quality of Life
MeSH terms: Neoplasms, Second Primary; Fatigue
Study type: Interventional

Summary: 
      Patients diagnosed with breast cancer who received assisted radiotherapy were recruited and
      the transcutaneous auricular vagus nerve stimulation (taVNS) was applied. The aim of of study
      is : 1) to study whether taVNS could improve the patient's fatigue, quality of life under
      radiotherapy or chemotherapy; 2) to investigate the effects of taVNS on the levels of
      patients' lymphocyte subsets and proinflammatory cytokines.
    

Detailed description: 
      A prospective, randomized, double-blind, parallel controlled trial was conducted. This trail
      is to recruit 288 patients. Patients were randomly assigned in 2:1 ratio. According to
      staging (stage I-II vs stage III), the participants were randomly divided into two groups: 1)
      sham taVNS with conventional radiotherapy (control group); 2) taVNS with conventional
      radiotherapy(intervention group). taVNS was conducted at every radiotherapy day. taVNS
      stimulation method: for taVNS group, the electrodes were attached to the tragus of left ear
      after skin preparation with an alcohol pad, the stimulation current was a single-phase
      rectangular pulse with the following stimulation parameters: duty circle: 60 s "on" periods
      and 10 s "off" periods; frequency: 30 Hz; pulse width: 200 μs; pulse amplitude of 0.5 mA to
      1.5 mA; stimulation time:30 min. For staVNS group, the clip electrodes were also placed on
      the left tragus but with no current output. The Chinese version of the Concise Fatigue Scale
      (BFI-C), the European Organization for Reasearch and Treatment of Cancer Quality of Life
      Questionnaire(EORTC QLQ-C30), Pittsburgh sleep quality index (PSQI) and Hospital Anxiety and
      Depression Scale (HADS) assessment, lymphocyte subpopulations,level of proinflammatory
      factors, blood routine testing and electrocardiogram testing were performed within 2 weeks
      before treatment (baseline), 4 weeks after intervention, at the end of chemoradiation, 1
      month and 4 month after the end of chemoradiation; weekly blood routine testing during
      intervention under radiotherapy and chemotherapy; the incidence of side effects and sleep
      quality score were evaluated at baseline, 2 weeks and 4 weeks after the intervention, at the
      end of radiotherapy and chemotherapy, and 1 month after the end of radiotherapy. The number
      of recruited participants met the statistical requirements.
    

Intervention name(s): Transcutaneous vagus nerve stimulation
Intervention type(s): Device
Intervention description(s): the transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cancer-related fatigue; Transcutaneous vagus nerve stimulation; Breast cancer; Radiotherapy