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Набор скоро начнётся NCT07685938

Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease

Фаза II С лечением Chest Wall Tumor Breast Cancer Lung Cancer Esophageal Cancer

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: Atorvastatin and Lisinopril, Placebo.
Кому может быть актуально
Состояния в реестре: Chest Wall Tumor, Breast Cancer, Lung Cancer, Esophageal Cancer. Базовые параметры: от 18 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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Обзор

Radiation therapy is an essential treatment for tumors in the chest area, including breast, lung, esophageal, mediastinal cancers, and spine metastases. Although technical advances have reduced treatment-related illness and death, radiation exposure to the heart can still cause substantial rates of radiation-induced heart disease (RIHD) among survivors. For example, about 21% of non-small cell lung cancer patients receiving a mean heart dose of 20 Gy or higher experience major adverse cardiac events (MACE) within 2 years. In breast cancer patients, the risk of MACE increases by about 7% for each additional Gy of mean heart dose. There is currently no established medication strategy to prevent or reduce RIHD. Preclinical and clinical studies show that statins and angiotensin-converting enzyme (ACE) inhibitors may help reduce radiation-induced heart disease (RIHD). Statins and ACE inhibitors are generally well tolerated, available as generic drugs, and commonly used to help prevent cardiovascular disease. They may protect the heart by reducing damage to blood vessel lining (endothelial damage), microvascular dysfunction, atherosclerosis, reduced blood flow (ischemia), and fibrosis (scarring). This study is a prospective, randomized, placebo-controlled phase II hybrid decentralized trial. Patients receiving standard radiation therapy and expected to receive an equivalent dose of at least 25 Gy (EQD2) to at least 10% of the heart will be randomly assigned to receive either: * placebo, or * Atorvastatin 20 mg plus Lisinopril 5 mg daily. The medications will be taken during radiation therapy and continued for 6 months after treatment. The study aims to determine whether the intervention can reduce radiation-related decreases in blood flow to the heart, measured using myocardial perfusion imaging, such as positron emission tomography (PET), which is commonly used to evaluate the risk of coronary heart disease.

Вмешательства

  • Препарат Atorvastatin and Lisinopril
    Patients will receive statins and angiotensin-converting enzyme (ACE) inhibitors.
  • Препарат Placebo
    Patients will receive placebo.

Первичные конечные точки

  • Percent difference in the radiation (RT)-induced reduction of myocardial perfusion [Срок оценки: Pre radiation therapy and 6-month post radiation therapy]
Вторичные конечные точки (4)
  • Percent Change in Radiation-Induced Myocardial Perfusion Reduction by Cardiac Dose: Placebo vs Statin and ACE Inhibitor Therapy [Срок оценки: Pre radiation therapy and 6-month post radiation therapy]
  • Change in for cardiac biomarker panel [Срок оценки: Pre radiation therapy and 3 months and 6-month post radiation therapy]
  • Correlation between cardiac stress and perfusion biomarkers and radiation dose [Срок оценки: Pre radiation therapy and 3 months and 6-month post radiation therapy]
  • Rates of major adverse cardiac events [Срок оценки: At follow-up of 1, 2, and 3 years.]

Критерии участия

Критерии включения

  • Written informed consent obtained to participate in the study and HIPAA
  • authorization for release of personal health information.
  • Subjects is willing and able to comply with study procedures based on the
  • judgement of the investigator.
  • Consent for serial blood draws and consent for use of biological specimens.
  • Age ≥ 18 years at the time of consent

Критерии исключения

  • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
  • Pre-existing use of a statin or ACE-inhibitor
  • Pre-existing hypotension

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT07685938 · LCCC2239-DCT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗