BridgeMD
New treatment option for Breast Cancer Survivors
Official title taVNS for Breast Cancer Pain and Symptom Management
ClinicalTrials.gov ID: NCT07500012
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79, women only
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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...
- have active inflammatory or malabsorptive gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease) that could confound...
- have taken antibiotics, probiotics, or gastrointestinal motility agents (e.g., laxatives, prokinetics) within the past 3 months, due to potential...
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tallahassee, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tallahassee, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.