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

NCT ID: NCT04563013

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2022-05-30

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.

Conditions

Breast Cancer; Cancer, Therapy-Related; Cancer-related Fatigue; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham taVNS

The participants under conventional radiotherapy were applied with sham taVNS at the left tragus with the power off for 30min. The intervention would last until to the end of conventional radiotherapy.

Group Type: SHAM_COMPARATOR

Transcutaneous vagus nerve stimulation

Intervention Type: DEVICE

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

taVNS

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.

Group Type: ACTIVE_COMPARATOR

Transcutaneous vagus nerve stimulation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

Xidian University

OTHER

Sponsor Role: lead

Responsible Party

Wei Qin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li-Na Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

the First Affiliated Hospital of the Air Force Medical University

Wei Qin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xidian University

Locations

Xidian University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

20200110

Identifier Type: -

Identifier Source: org_study_id