Clinical trial NCT04563013: Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients
Official title: Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients' Fatigue, Quality of Life and Lymphopenia After Radiotherapy or Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer, Therapy-Related
Cancer-related Fatigue
Quality of Life
Keywords: Cancer-related fatigue
Transcutaneous vagus nerve stimulation
Breast cancer
Radiotherapy
Lead sponsor: Xidian University
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
First posted: 2020-09-24
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 261 patients. Patients were randomly assigned in 2:1 ratio to two groups: 1) taVNS with conventional radiotherapy(intervention group); 2)sham taVNS with conventional radiotherapy (control 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 Fatigue Scale (BFI), 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, end of chemoradiation and 1 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.

Eligibility criteria: Inclusion Criteria:

1. Participants diagnosed with breast cancer, suitable for adjuvant radiotherapy after surgery;
2. Eastern Cooperative Oncology Group (ECOG) physical condition score: 0\~1 point.

Exclusion Criteria:

1. Participants with organic brain lesions (cerebral hemorrhage, large-area cerebral infarction, encephalitis, epilepsy, etc.);
2. Participants with peptic ulcer, arrhythmia, or cardiac corrected QT interval\> 450ms;
3. Participants who have slow breathing (less than 10 breaths per minute);
4. Participants who are or have been diagnosed with other major diseases (coronary heart disease, pulmonary heart disease, etc.);
5. Participants who are currently or have been diagnosed with mental disorders other than major depressive disorder;
6. Participants who are or have participated in vagus nerve or transcranial electrical stimulation treatment for less than 3 months;
7. Participants who are not suitable for vagus nerve stimulation treatment;
8. Participants who refuse to sign informed consent.

Primary outcomes:
measure: the score of fatigue at 1 month
timeFrame: The taVNS treatment lasted about five weeks, data were collected at 1 month after the end of the taVNS treatment
Secondary outcomes:
measure: the scores of HADS at End and at 1 month
timeFrame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
measure: the scores of PSQI at End and at 1 month
timeFrame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
measure: the scores of EORTC QLQ-C30 at End and at 1 month
timeFrame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
measure: the change of cell counts of blood cells from baseline to End and to 1M.
timeFrame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
measure: the change in IL-6 level from baseline to End and to 1M.
timeFrame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
measure: the change in CRP level from baseline to End and to 1M.
timeFrame: The intervention lasted about five weeks, data were collected at the end of RT and taVNS treatment (End) and 1 month after the end of taVNS treatment (1M)
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xidian University
state: Shaanxi
Study officials:
affiliation: the First Affiliated Hospital of the Air Force Medical University
name: Li-Na Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xidian University
name: Wei Qin, Doctor
role: PRINCIPAL_INVESTIGATOR
References: