taVNS for Breast Cancer Pain and Symptom Management | NCT07500012

NCT07500012

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active taVNS intervention	Active Comparator	practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)	Device: Active taVNS
Sham taVNS	Sham Comparator	practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)	Device: Sham taVNS

Name	Type	Description	Arm Group Labels	Other Names
Active taVNS	Device	practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)	Active taVNS intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	Baseline and 4 weeks and 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms