Clinical trial · Interventional
Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
NCT05921253CI-TRIAL-00101662OU-SCC-NCANrecruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to determine if low level vagus nerve stimulation will lead to improvement in heart function, heart rate variation, and in the levels of certain chemical markers of inflammation in study participants' blood.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PARASYM neuromodulation device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Self administration of Low Level Tragus Stimulation (LLTS; Placebo)
- description
- PARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days.
- interventionNames
- Device: PARASYM neuromodulation device
- type
- EXPERIMENTAL
- label
- Self administration of LLTS
- description
- PARASYM neuromodulation device will be placed in a pre-determined position (different from that of the placebo) of one ear for 1 hour every day for 14 days.
- interventionNames
- Device: PARASYM neuromodulation device
Primary outcomes (1)
- measure
- Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients (\>18 years) who have received anthracycline-based therapy for breast cancer or lymphoma within the last 30 days
* A least 1 of following additional criteria:
* previous chest radiation
. Age\>50
* type 2 diabetes mellitus
* hypertension
* current smoking
* obesity (BMI ≥ 30)
* previous myocardial infarction
* established atherosclerotic heart disease or significant valve disease. chronic kidney disease
Exclusion Criteria:
* Atrial paced rhythm
* History of seizure currently on treatment
* History of vasovagal syncope
* End stage liver or kidney diseaseReferences
Publications (0)
Data not yet available
No reference posted for this study.