Breast CancerEarly Phase 1OU-SCC-NCANNCT05921253
Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
A Early Phase 1 study testing PARASYM neuromodulation device in people with Breast Cancer and Lymphoma, run by University of Oklahoma at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer, Lymphoma
- What is being tested?
- PARASYM neuromodulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2023to Sep 2028
- Phase
- Early Phase 1
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- current smoking
- obesity (BMI ≥ 30)
- previous myocardial infarction
- established atherosclerotic heart disease or significant valve disease. chronic kidney disease
Who cannot join
- Atrial paced rhythm
- History of seizure currently on treatment
- History of vasovagal syncope
- End stage liver or kidney disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
SCC IIT Office, 405-271-8777, SCC-IIT-Office@ouhsc.edu
Tarun W. Dasari, MD, MPH
- Recruiting
Stephenson Cancer Center- Tulsa
Tulsa, Oklahoma, 74104
Lead Nurse, SCC-IIT-Office@ouhsc.edu
Laura K Brett, MD
About this study
Official title: Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
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.
Read the detailed description
Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.
- Conditions
- Breast Cancer, Lymphoma
- Being tested
- PARASYM neuromodulation device
- Keywords
- Stimulation Device, Vagus Nerve Stimulator
- Medical subject headings
- Breast Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARASYM neuromodulation deviceDevice
Also called Experimental
Patients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a preset position of one ear for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study.
PARASYM neuromodulation deviceDevice
Also called Placebo
Patients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a different position of one ear compared to the "experimental arm" for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study.
| Study group | Role | What they receive |
|---|---|---|
| Self administration of Low Level Tragus Stimulation (LLTS; Placebo) | Placebo comparator | PARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days. Receives: Device: PARASYM neuromodulation device |
| Self administration of LLTS | Experimental | 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. Receives: Device: PARASYM neuromodulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
An echocardiogram will be performed on patients at baseline and at follow up (14 days after start of intervention). The percentage change of GLS and left ventricular ejection fraction (LVEF) will be compared at baseline and follow up in patients receiving cardiotoxic chemotherapy.
Measured: 2 weeks
Secondary outcomes (2)
Effects of LLTS on autonomic tone
Measure change in autonomic tone by 15-minute Heart Rate Variability at baseline and follow up. (2 week) HRV has time and frequency domain numbers that are continuous variables from 0-100 and more.
Measured: 2 weeks
Effects of LLTS on oxidative stress
Analyze markers of oxidative stress in serum collected from patients at baseline and at follow up. Serum will be analyzed for oxidative stress before and after use of the TENS device. Results are expressed in Units - continuous variable.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Dec 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, sham controlled, double-blinded study of low-level tragus stimulation vs. sham treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarun W. Dasari, MD, MPH, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921253
- Sponsor's protocol ID
- OU-SCC-NCAN
- Acronym
- OU-SCC-NCAN
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
- ClinicalTrials.gov ID
- NCT05921253
- Acronym / sponsor ID
- OU-SCC-NCAN / OU-SCC-NCAN
- Conditions
- Breast Cancer, Lymphoma
- Keywords
- Stimulation Device, Vagus Nerve Stimulator
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 Jun 2023 (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.
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.
Detailed description
Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, sham controlled, double-blinded study of low-level tragus stimulation vs. sham treatment.
| Arm | Type | Receives |
|---|---|---|
| Self administration of Low Level Tragus Stimulation (LLTS; Placebo) | Placebo comparator | Device: PARASYM neuromodulation devicePARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days. |
| Self administration of LLTS | Experimental | Device: PARASYM neuromodulation devicePARASYM 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- . Age>50
Key exclusion criteria (4 listed)
- Atrial paced rhythm
- History of seizure currently on treatment
- History of vasovagal syncope
- End stage liver or kidney disease
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 |
|---|---|---|
| PARASYM neuromodulation deviceAlso: ExperimentalPatients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a preset position of one ear for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study. | Device | Self administration of LLTS |
| PARASYM neuromodulation deviceAlso: PlaceboPatients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a different position of one ear compared to the "experimental arm" for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study. | Device | Self administration of Low Level Tragus Stimulation (LLTS; Placebo) |
Primary outcome
Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
Time frame: 2 weeks
An echocardiogram will be performed on patients at baseline and at follow up (14 days after start of intervention). The percentage change of GLS and left ventricular ejection fraction (LVEF) will be compared at baseline and follow up in patients receiving cardiotoxic chemotherapy.
2 secondary outcomes
Effects of LLTS on autonomic tone
Time frame: 2 weeks
Effects of LLTS on oxidative stress
Time frame: 2 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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Tarun W. Dasari, MD, MPH principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PARASYM neuromodulation device in people with Breast Cancer and Lymphoma, run by University of Oklahoma at 2 sites 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 10 inclusion and 4 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 SCC IIT Office (4052718777, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS) (time frame: 2 weeks). 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 27 Oct 2026.