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.
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.