Breast CancerNCT04563013
Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients
A study testing Transcutaneous vagus nerve stimulation in people with Breast Cancer and Cancer, Therapy-Related, run by Xidian University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Cancer, Therapy-Related, Cancer-related Fatigue
- What is being tested?
- Transcutaneous vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2020to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with breast cancer, suitable for adjuvant radiotherapy after surgery;
- Eastern Cooperative Oncology Group (ECOG) physical condition score: 0~1 point.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients' Fatigue, Quality of Life and Lymphopenia After Radiotherapy or Chemotherapy
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.
Read the 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.
- Being tested
- Transcutaneous vagus nerve stimulation
- Keywords
- Cancer-related fatigue, Transcutaneous vagus nerve stimulation, Breast cancer, Radiotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve stimulationDevice
the transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Sham taVNS | Sham comparator | 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. Receives: Device: Transcutaneous vagus nerve stimulation |
| taVNS | Active comparator | 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. Receives: Device: Transcutaneous vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score of fatigue at 1 month
For fatigue degree evaluation, the Brief Fatigue Inventory (BFI) was used. The score of fatigue in two groups will be evaluated by BFI and will be compared. The scale uses the 11-point scoring method, whereby 0 points indicates no fatigue and 10 points the most severe fatigue. A higher score indicates more severe fatigue. The BFI included three fatigue severity items and six fatigue interference items. Three fatigue severity items ask patients to rate the severity of their fatigue at its "worst", "usual" and "now" during the past 24 h and another six fatigue interference items describe how much fatigue has interfered with different aspects of the patient's life during past 24 h, including general activity, mood, walking ability, normal work, relationships with other people and enjoy of life.
Measured: The taVNS treatment lasted about five weeks, data were collected at 1 month after the end of the taVNS treatment
Secondary outcomes (6)
the scores of HADS at End and at 1 month
For depression and anxiety degree evaluation, the Hospital Anxiety and Depression Scale (HADS) was used. The HADS is a brief 14-item scale, with seven items in each of the anxiety and depression dimension scored from 0 to 3, resulting in scale scores ranging from 0 to 21.
Measured: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the scores of PSQI at End and at 1 month
For sleep evaluation, the Pittsburgh Sleep Quality Index (PSQI) was used. The PSQI was a 19-item self-report instrument that includes seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction.
Measured: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the scores of EORTC QLQ-C30 at End and at 1 month
The quality of life was evaluated by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). It included a total of 30 entries, which were divided into 15 domains; among these, there were 5 functional domains (body, role, cognition, mood, and social function), 3 symptom domains (fatigue, pain, and nausea and vomiting), 1 overall health status/quality of life area and 6 single entries (each as a domain). The higher the score for the functional domains and overall health status, the better the functional status and quality of life. The final standardized score ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the change of cell counts of blood cells from baseline to End and to 1M.
Clinical and laboratory parameters, including the cell counts of white blood cell, lymphocyte, neutrophil, platelet, the value of hemoglobin, were extracted from the electronic medical record for all patients.
Measured: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the change in IL-6 level from baseline to End and to 1M.
The levels of interleukin-6 (IL-6) was extracted from the electronic medical record for all patients.
Measured: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the change in CRP level from baseline to End and to 1M.
The levels of C-reactive protein (CRP) was extracted from the electronic medical record for all patients.
Measured: The intervention lasted about five weeks, data were collected at the end of RT and taVNS treatment (End) and 1 month after the end of taVNS treatment (1M)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start23 Sep 2020
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xidian University
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Principal investigator, Wei Qin, Xidian University
- Investigators
- Li-Na Zhao, Doctor, Principal investigator, the First Affiliated Hospital of the Air Force Medical UniversityWei Qin, Doctor, Principal investigator, Xidian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563013
- Sponsor's protocol ID
- 20200110
- Status last verified
- Mar 2024
- First submitted
- 14 Sep 2020
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be available by the publication of articles
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients' Fatigue, Quality of Life and Lymphopenia After Radiotherapy or Chemotherapy
- ClinicalTrials.gov ID
- NCT04563013
- Acronym / sponsor ID
- 20200110
- Keywords
- Cancer-related fatigue, Transcutaneous vagus nerve stimulation, Breast cancer, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Xidian UniversityUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham taVNS | Sham comparator | Device: Transcutaneous vagus nerve stimulationThe 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. |
| taVNS | Active comparator | Device: Transcutaneous vagus nerve stimulationFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants diagnosed with breast cancer, suitable for adjuvant radiotherapy after surgery;
- Eastern Cooperative Oncology Group (ECOG) physical condition score: 0~1 point.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagus nerve stimulationthe transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min. | Device | Sham taVNS, taVNS |
Primary outcome
the score of fatigue at 1 month
Time frame: The taVNS treatment lasted about five weeks, data were collected at 1 month after the end of the taVNS treatment
For fatigue degree evaluation, the Brief Fatigue Inventory (BFI) was used. The score of fatigue in two groups will be evaluated by BFI and will be compared. The scale uses the 11-point scoring method, whereby 0 points indicates no fatigue and 10 points the most severe fatigue. A higher score indicates more severe fatigue. The BFI included three fatigue severity items and six fatigue interference items. Three fatigue severity items ask patients to rate the severity of their fatigue at its "worst", "usual" and "now" during the past 24 h and another six fatigue interference items describe how much fatigue has interfered with different aspects of the patient's life during past 24 h, including general activity, mood, walking ability, normal work, relationships with other people and enjoy of life.
6 secondary outcomes
the scores of HADS at End and at 1 month
Time frame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the scores of PSQI at End and at 1 month
Time frame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the scores of EORTC QLQ-C30 at End and at 1 month
Time frame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the change of cell counts of blood cells from baseline to End and to 1M.
Time frame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the change in IL-6 level from baseline to End and to 1M.
Time frame: The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment
the change in CRP level from baseline to End and to 1M.
Time frame: The intervention lasted about five weeks, data were collected at the end of RT and taVNS treatment (End) and 1 month after the end of taVNS treatment (1M)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: Yes. the data will be available by the publication of articles
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Na Zhao, Doctor principal investigator
the First Affiliated Hospital of the Air Force Medical University
Wei Qin, Doctor principal investigator
Xidian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagus nerve stimulation in people with Breast Cancer and Cancer, Therapy-Related, run by Xidian University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of fatigue at 1 month (time frame: The taVNS treatment lasted about five weeks, data were collected at 1 month after the end of the taVNS treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.