Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients

Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients' Fatigue, Quality of Life and Lymphopenia After Radiotherapy or Chemotherapy

Sponsors

Lead Sponsor: Xidian University

Collaborator: The First Affiliated Hospital of the Fourth Military Medical University

Source Xidian University
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.

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.

Overall Status Recruiting
Start Date 2020-04-03
Completion Date 2021-12-30
Primary Completion Date 2021-12-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the score of fatigue 4 weeks after intervention
Secondary Outcome
Measure Time Frame
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
the life quality of participants baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy
the depression level of participants baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy
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
proinflammatory factors in blood circulation baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy
the level of sleep quality baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy
Lymphocyte nadirs baseline(during 2 weeks before intervention), 4 weeks after intervention, 1 month and 4 month after the therapy
Enrollment 130
Condition
Intervention

Intervention Type: Device

Intervention Name: Transcutaneous vagus nerve stimulation

Description: the transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min.

Eligibility

Criteria:

Inclusion Criteria: 1. Participants diagnosed with nasopharyngeal cancer, esophageal cancer, lung cancer, or cervical cancer, suitable for radical radiotherapy or chemotherapy; 2. Participants diagnosed with rectal cancer, suitable for neoadjuvant radiotherapy or chemotherapy before surgery; 3. Participants diagnosed with breast cancer, suitable for adjuvant radiotherapy after surgery; 4. 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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Hui Deng, Phd

Phone: 18811796557

Phone Ext.: 18811796557

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Xidian University Wei Qin, Doctor +8615691826100 [email protected] Li-Na Zhao, Doctor Principal Investigator Wei Qin, Doctor Principal Investigator
Location Countries

China

Verification Date

2021-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Xidian University

Investigator Full Name: Wei Qin

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Sham tVNS

Type: Sham Comparator

Description: 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.

Label: tVNS

Type: Active Comparator

Description: 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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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