This phase I trial tests whether low level vagus nerve stimulation (neuromodulation) will lead to improvement in heart function, heart rate variation, and in the levels of certain chemical markers of inflammation in the blood of patients with breast cancer or lymphoma. Cardiotoxic chemotherapy is used to treat breast cancer and hematological malignancies (blood-related tumor cells) such as lymphoma. Such treatment predisposes patients to cardiotoxicity leading to cancer therapy related cardiac dysfunction (CTRCD). Noninvasive neuromodulation, using low-level tragus (tongue-like projection of the outer ear) stimulation (LLTS), is a novel, safe, non-invasive technique that provides a great potential to alter autonomic imbalance, improve global longitudinal strain (GLS) and reduce oxidative stress. Information gathered from this study will help doctors learn how neuromodulation may improve heart function, heart rate variation and inflammation after completion of chemotherapy for patients with breast cancer or lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05921253.
Locations matching your search criteria
United States
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences CenterStatus: Active
Contact: Tarun Dasari
Phone: 405-271-4742
PRIMARY OBJECTIVE:
I. Quantitatively measure effects of LLTS on global longitudinal strain in patients receiving cardiotoxic chemotherapy.
SECONDARY OBJECTIVES:
I. Measure effect of LLTS on autonomic tone and oxidative stress.
II. To explore the effects of LLTS to reduce cardiovascular risks that precede development of CTRCD.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients use the sham PARASYM stimulator daily (QD) for 1 hour at home to deliver low level electrical stimulation to ear for 14 days. Patients also undergo heart ultrasound and blood sample collection throughout the study.
GROUP II: Patients use the PARASYM stimulator daily QD for 1 hour at home to deliver low level electrical stimulation to ear for 14 days. Patients also undergo heart ultrasound and blood sample collection throughout the study.
After completion of study intervention, patients are followed at 2 weeks.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationUniversity of Oklahoma Health Sciences Center
Principal InvestigatorTarun Dasari
