Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients
Study Details
Study Description
Brief Summary
Patients diagnosed with nasopharyngeal cancer, esophageal cancer, lung cancer, cervical cancer, rectal cancer, or breast cancer who received radical radiotherapy/neoadjuvant/assisted radiotherapy were recruited and the transcutaneous vagal nerve stimulation (tVNS) was applied. The aim of of study is : 1) to study whether tVNS could improve the patient's fatigue, quality of life under radiotherapy or chemotherapy; 2) to investigate the effects of transcutaneous VNS on the levels of patients' lymphocyte subsets and proinflammatory cytokines.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A prospective, randomized, double-blind, parallel controlled trial was conducted. This trail is to recruit 130 patients diagnosed with above specific types of cancer undergoing radical radiotherapy/neoadjuvant/adjuvant radiotherapy. Participants were randomly assigned to the two groups with 65 in each group. According to treatment mode (radical radiotherapy vs neoadjuvant or adjuvant radiotherapy) and staging (stage I-II vs stage III), the participants were randomly divided into two groups: 1) sham tVNS with conventional radiotherapy and chemotherapy (control group); 2) tVNS with conventional radiotherapy and chemotherapy (intervention group). tVNS was conducted at every radiotherapy day for at least 4 weeks. tVNS stimulation method: in the control group, the ear clip electrodes were clamped at the earlobe; in the intervention group, the ear clip electrode was clamped at the tragus. Stimulation duration would last for 30 minutes, and the stimulation intensity was adjusted to the minimum value of pain threshold. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Sham tVNS The participants under conventional radiochemotherapy were applied with sham tVNS at the earlobe for 30min and the current intensity was set according to the minimum value of pain threshold. The intervention would last until to the end of conventional radiochemotherapy. |
Device: Transcutaneous vagus nerve stimulation
the transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min.
|
| Active Comparator: tVNS The participants under conventional radiochemotherapy were applied with transcutaneous vagus nerve stimulation at the tragus for 30min and the current intensity was set according to the minimum value of pain threshold. The intervention would last until to the end of conventional radiochemotherapy. |
Device: Transcutaneous vagus nerve stimulation
the transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min.
|
Outcome Measures
Primary Outcome Measures
- the score of fatigue [4 weeks after intervention]
the score of fatigue in two groups will be evaluated by BFI-C and will be compared
Secondary Outcome Measures
- the change of the fatigue score at baseline and after intervention [baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy]
compare the change of fatigue levels between two groups
- the life quality of participants [baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy]
the life quality will be evaluated by QLQ-C30 (V3.0) of Chinese version
- the depression level of participants [baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy]
the depression level will be evaluated by HADS
- Lymphocytes and their subpopulations in blood circulation [baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy]
the absolute value of lymphocytes ,the ratio of its subpopulations and the decline ratio will be detected and analyzed.
- proinflammatory factors in blood circulation [baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy]
the levels of proinflammatory factors, such as tumor necrosis factor-α (TNF-α) , interleukin-6 (IL-6) and C-response protein (CRP) in serum were detected.
- the level of sleep quality [baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy]
the level of sleep quality will be evaluated by PSIQ
- Lymphocyte nadirs [baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy]
the minimum value of lymphocytes and its difference to that at baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants diagnosed with nasopharyngeal cancer, esophageal cancer, lung cancer, or cervical cancer, suitable for radical radiotherapy or chemotherapy;
-
Participants diagnosed with rectal cancer, suitable for neoadjuvant radiotherapy or chemotherapy before surgery;
-
Participants diagnosed with breast cancer, suitable for adjuvant radiotherapy after surgery;
-
Eastern Cooperative Oncology Group (ECOG) physical condition score: 0~1 point.
Exclusion Criteria:
-
Participants with organic brain lesions (cerebral hemorrhage, large-area cerebral infarction, encephalitis, epilepsy, etc.);
-
Participants with peptic ulcer, arrhythmia, or cardiac corrected QT interval> 450ms;
-
Participants who have slow breathing (less than 10 breaths per minute);
-
Participants who are or have been diagnosed with other major diseases (coronary heart disease, pulmonary heart disease, etc.);
-
Participants who are currently or have been diagnosed with mental disorders other than major depressive disorder;
-
Participants who are or have participated in vagus nerve or transcranial electrical stimulation treatment for less than 3 months;
-
Participants who are not suitable for vagus nerve stimulation treatment;
-
Participants who refuse to sign informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xidian University | Xi'an | Shaanxi | China |
Sponsors and Collaborators
- Xidian University
- The First Affiliated Hospital of the Fourth Military Medical University
Investigators
- Principal Investigator: Li-Na Zhao, Doctor, The First Affiliated Hospital of the Fourth Military Medical University
- Principal Investigator: Wei Qin, Doctor, Xidian University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20200110