taVNS for Breast Cancer Pain and Symptom Management
ConditionBreast Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-79
SponsorFlorida State University
About this trial
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 survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Active taVNS
Devicepractice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
Sham taVNS
Devicepractice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active taVNS interventionActive comparator 1 intervention
Group B: Sham taVNSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 4 weeks and 8 weeks2
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.
Time frame
4 weeks3
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.
Time frame
Baseline and 4 weeks and 8 weeks4
Satisfaction in implementing taVNS
Satisfaction in using the taVNS will be measured using self-reported data including online self-monitoring diary, surveys, and interviews.
Time frame
Baseline and 4 weeks and 8 weeksSecondary outcomes
1
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.
Time frame
Baseline and 4 weeks and 8 weeks2
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.
Time frame
Baseline and 4 weeks and 8 weeks3
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.
Time frame
Baseline and 4 weeks and 8 weeks4
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.
Time frame
Baseline and 4 weeks and 8 weeksSponsors and contacts
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Source ClinicalTrials.gov