Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer-related Fatigue | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Cancer, Therapy-Related | Therapy-Related Malignant Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcutaneous vagus nerve stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Sham taVNS
- description
- 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.
- interventionNames
- Device: Transcutaneous vagus nerve stimulation
- type
- ACTIVE_COMPARATOR
- label
- taVNS
- description
- 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.
- interventionNames
- Device: Transcutaneous vagus nerve stimulation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available