Breast Cancer SurvivorsNCT07500012
taVNS for Breast Cancer Pain and Symptom Management
A study testing Active taVNS in people with Breast Cancer Survivors, run by Florida State University at 1 site in United States.
Trial summary
1. To evaluate the feasibility and acceptability of a home-based taVNS intervention and follow-up for pain and symptom management in breast cancer survivors. 2. To investigate the impact of taVNS on secondary outcomes, including pain, anxiety, depression, fatigue, and the brain-gut axis (BGA) in breast cancer… Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are aged 18-79 years older;
- have histologically confirmed Stage 0, I, II, or III breast cancer;
- had completed their primary cancer treatment (surgery, radiotherapy, chemotherapy) and are currently on a stable survivorship care plan (e.g., endocrine therapy, supportive care), with no major treatment changes expected during the study;
- have experienced pain with a severity of 4 or greater out of 10 for at least ten days in the last month;
- are committed to maintaining the current treatment plan (e.g., endocrine therapy, supportive care) during the study;
- have reliable internet access;
- are willing to provide stool samples and undergo fNIRS brain imaging procedures;
- are able to read and understand English and provide written informed consent.
Who cannot join
- have metastatic breast cancer (Stage IV);
- have a current diagnosis of another active cancer;
- have a history of significant cardiac conditions, such as bradycardia, arrhythmia, recent myocardial infarction, or heart failure;
- have been diagnosed with a severe psychiatric illness (e.g., schizophrenia, bipolar I disorder with active psychosis) that could interfere with adherence to study procedures;
- have active inflammatory or malabsorptive gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease) that could confound gut microbiota results;
- have taken antibiotics, probiotics, or gastrointestinal motility agents (e.g., laxatives, prokinetics) within the past 3 months, due to potential disruption of gut microbiota;
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- have a progressive neurological condition (e.g., Parkinson's disease, epilepsy, multiple sclerosis) that may impact fNIRS data quality or study participation;
- have a history of surgical or pharmacological vagotomy or are currently receiving implanted vagus nerve stimulation therapy, because of potential interference with autonomic regulation and taVNS mechanisms;
- have an active electronic or metallic implant (e.g., cochlear implant, pacemaker, neurostimulator) or other electronic/metallic device in the head or neck area, which may be contraindicated for taVNS;
- are pregnant, breastfeeding, or planning to become pregnant during the study period;
- have had a recent initiation or dose change of pain medications (e.g., opioids, neuropathic agents) within the past 4 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32306
JIE CHEN, 8506450657, jc22db@fsu.edu
About this study
Official title: Home-based Pain and Symptom Management for Breast Cancer Survivors: a Triple- Blinded RCT Pilot Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- To evaluate the feasibility and acceptability of a home-based taVNS intervention and follow-up for pain and symptom management in breast cancer survivors.
- To investigate the impact of taVNS on secondary outcomes, including pain, anxiety, depression, fatigue, and the brain-gut axis (BGA) in breast cancer survivors.
- Conditions
- Breast Cancer Survivors
- Being tested
- Active taVNS, Sham taVNS
- Keywords
- pain, symptoms, transcutaneous auricular vagus nerve stimulation (taVNS)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active taVNSDevice
practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
Sham taVNSDevice
practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS intervention | Active comparator | practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions) Receives: Device: Active taVNS |
| Sham taVNS | Sham comparator | practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions) Receives: Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing taVNS - Retention rates
Feasibility will be assessed by evaluating the retention rate of participants who complete the taVNS sessions at 4 weeks and the follow-up at week 8. Retention rates will be calculated by comparing the number of participants who complete these timepoints with the baseline data.
Measured: Baseline and 4 weeks and 8 weeks
Adherence of implementing taVNS - Duration of usage
Participants will log the frequency, time, and duration of daily taVNS device use in an online diary through the REDCap system.
Measured: 4 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in using the taVNS will be measured using self-reported data, including online self-monitoring diary, surveys, and interviews. Adverse events (AEs) will be monitored daily using the online diary with a preset form, including a 10-item survey to assess daily AEs of taVNS on 0-10 Likert scales.
Measured: Baseline and 4 weeks and 8 weeks
Satisfaction in implementing taVNS
Satisfaction in using the taVNS will be measured using self-reported data including online self-monitoring diary, surveys, and interviews.
Measured: Baseline and 4 weeks and 8 weeks
Secondary outcomes (12)
Change in pain intensity and interference
Pain Inventory (BPI) will be used to assess the multidimensional aspects of pain, its location, intensity, and interference. A higher score indicated higher pain intensity with 0 indicating no pain and 10 indicating the worst pain. A higher score of pain interference means daily functions are more impacted by pain, and 0 indicates no pain interference, and 10 means the worst pain interference.
Measured: Baseline and 4 weeks and 8 weeks
Change in chronic pain self-efficacy
Chronic Pain Self-Efficacy Scale (CPSES) will be used to measure pain self-efficacy with scores from 0-100, higher scores indicating improved self-efficacy.
Measured: Baseline and 4 weeks and 8 weeks
Changes in quantitative sensory testing (QST)
Quantitative sensory testing (QST) will be used to measure sensitivity to experimental pain with standardized stimuli to test both nociceptive and non-nociceptive systems.
Measured: Baseline and 4 weeks and 8 weeks
Changes in conditioned pain modulation (CPM)
CPM will be used to determine the net effect of various facilitating and inhibiting systems exerting their activity at spinal or supraspinal levels. A phasic noxious stimulus (cold) will be applied in conjunction with a tonic noxious conditioning stimulus (pressure) applied to a distant body site on the forearm. Participants' self-reported pain intensity by NRS during the test will be recorded.
Measured: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Physical Function
The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the physical function. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.
Measured: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Anxiety
The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the anxiety. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.
Measured: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Depression
The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring depression. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.
Measured: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Fatigue
The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring fatigue. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.
Measured: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Sleep Disturbance
The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring sleep disturbance. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.
Measured: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Ability to Participate in Social Roles and Activities
The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the the ability to participate in social roles and activities. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.
Measured: Baseline and 4 weeks and 8 weeks
Changes in pain-related cortical response
Cortical activity associated with pain stimuli will be assessed utilizing a continuous-wave, multichannel functional near-infrared spectroscopy (fNIRS) imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) equipped with three semiconductor lasers emitting at 780, 805, and 830 nm. Optical data will be gathered while subjects undergo thermal pain stimulation.
Measured: Baseline and 4 weeks and 8 weeks
Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut
The 16S rRNA V4 region will be amplified and sequenced by using stool samples to depict the fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut.
Measured: Baseline and 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start24 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Chen, PhD, RN, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500012
- Sponsor's protocol ID
- STUDY00006413
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Deidentified data will be available upon reasonable request. Requests to access these datasets should be directed to jc22db@fsu.edu.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Pain and Symptom Management for Breast Cancer Survivors: a Triple- Blinded RCT Pilot Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- ClinicalTrials.gov ID
- NCT07500012
- Acronym / sponsor ID
- STUDY00006413
- Conditions
- Breast Cancer Survivors
- Keywords
- pain, symptoms, transcutaneous auricular vagus nerve stimulation (taVNS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 30 Mar 2026 (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.
- To evaluate the feasibility and acceptability of a home-based taVNS intervention and follow-up for pain and symptom management in breast cancer survivors.
- To investigate the impact of taVNS on secondary outcomes, including pain, anxiety, depression, fatigue, and the brain-gut axis (BGA) in breast cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active taVNS intervention | Active comparator | Device: Active taVNSpractice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions) |
| Sham taVNS | Sham comparator | Device: Sham taVNSpractice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- are aged 18-79 years older;
- have histologically confirmed Stage 0, I, II, or III breast cancer;
- had completed their primary cancer treatment (surgery, radiotherapy, chemotherapy) and are currently on a stable survivorship care plan (e.g., endocrine therapy, supportive care), with no major treatment changes expected during the study;
- have experienced pain with a severity of 4 or greater out of 10 for at least ten days in the last month;
- are committed to maintaining the current treatment plan (e.g., endocrine therapy, supportive care) during the study;
Key exclusion criteria (11 listed)
- have metastatic breast cancer (Stage IV);
- have a current diagnosis of another active cancer;
- have a history of significant cardiac conditions, such as bradycardia, arrhythmia, recent myocardial infarction, or heart failure;
- have been diagnosed with a severe psychiatric illness (e.g., schizophrenia, bipolar I disorder with active psychosis) that could interfere with adherence to study procedures;
- have active inflammatory or malabsorptive gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease) that could confound gut microbiota results;
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 |
|---|---|---|
| Active taVNSpractice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions) | Device | Active taVNS intervention |
| Sham taVNSpractice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions) | Device | Sham taVNS |
Primary outcome
Feasibility of implementing taVNS - Retention rates
Time frame: Baseline and 4 weeks and 8 weeks
Feasibility will be assessed by evaluating the retention rate of participants who complete the taVNS sessions at 4 weeks and the follow-up at week 8. Retention rates will be calculated by comparing the number of participants who complete these timepoints with the baseline data.
Adherence of implementing taVNS - Duration of usage
Time frame: 4 weeks
Participants will log the frequency, time, and duration of daily taVNS device use in an online diary through the REDCap system.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Baseline and 4 weeks and 8 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in using the taVNS will be measured using self-reported data, including online self-monitoring diary, surveys, and interviews. Adverse events (AEs) will be monitored daily using the online diary with a preset form, including a 10-item survey to assess daily AEs of taVNS on 0-10 Likert scales.
Satisfaction in implementing taVNS
Time frame: Baseline and 4 weeks and 8 weeks
Satisfaction in using the taVNS will be measured using self-reported data including online self-monitoring diary, surveys, and interviews.
12 secondary outcomes
Change in pain intensity and interference
Time frame: Baseline and 4 weeks and 8 weeks
Change in chronic pain self-efficacy
Time frame: Baseline and 4 weeks and 8 weeks
Changes in quantitative sensory testing (QST)
Time frame: Baseline and 4 weeks and 8 weeks
Changes in conditioned pain modulation (CPM)
Time frame: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Physical Function
Time frame: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Anxiety
Time frame: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Depression
Time frame: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Fatigue
Time frame: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Sleep Disturbance
Time frame: Baseline and 4 weeks and 8 weeks
Changes in symptoms: Ability to Participate in Social Roles and Activities
Time frame: Baseline and 4 weeks and 8 weeks
Changes in pain-related cortical response
Time frame: Baseline and 4 weeks and 8 weeks
Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut
Time frame: Baseline and 4 weeks and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No. Deidentified data will be available upon reasonable request. Requests to access these datasets should be directed to jc22db@fsu.edu.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active taVNS in people with Breast Cancer Survivors, run by Florida State University at 1 site in United States.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Chen (850-645-0657, jc22db@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing taVNS - Retention rates (time frame: Baseline and 4 weeks and 8 weeks). The study lists 4 primary outcomes in all. 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 30 Mar 2026.