Идёт набор NCT05921253

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Ранняя фаза I С лечением Breast Cancer Lymphoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: PARASYM neuromodulation device, PARASYM neuromodulation device.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Lymphoma. Базовые параметры: 18 лет — 99 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)

Обзор

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.

Подробное описание

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.

Вмешательства

Устройство PARASYM neuromodulation device
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.
Устройство PARASYM neuromodulation device
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.

Первичные конечные точки

Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS) [Срок оценки: 2 weeks]

Вторичные конечные точки (2)

Effects of LLTS on autonomic tone [Срок оценки: 2 weeks]
Effects of LLTS on oxidative stress [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

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