Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
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: Pentoxifylline 400mg plus chemotherapy.
- Кому может быть актуально
- Состояния в реестре: Doxorubicin Induced Cardiotoxicity, Breast Cancer. Базовые параметры: 18 лет — 60 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The goal of this clinical trial is to evaluate the cardioprotective effect of pentoxifylline against doxorubicin-induced cardiotoxicity in breast cancer patients. The main questions it aims to answer are: 1. What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not? 2. What are the changes in serum levels of N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), and TNF-α (secondary outcomes) in breast cancer patients receiving pentoxifylline compared to those who do not? Researcher will compare breast cancer patients receiving standard chemotherapy alone (Group one: Positive control group; n=23) to breast cancer patients receiving standard chemotherapy plus pentoxifylline (Group two: pentoxifylline group; n=23) to see if pentoxifylline mitigates the cardiac side effects associated with doxorubicin treatment. Participants will: Be randomized to receive either a chemotherapeutic regimen alone or with pentoxifylline.
Вмешательства
- Препарат Pentoxifylline 400mg plus chemotherapy
patient will receive standard chemotherapy for breast cancer plus pentoxifylline 400 mg orally 3 times per day with meals.
Первичные конечные точки
- change in ejection fraction [Срок оценки: 3 MONTHS]
Вторичные конечные точки (1)
- changes in serum levels of the measured biological markers [Срок оценки: 3 MONTHS]
Критерии участия
Критерии включения
- Age ≥18 years old.
- Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
- Patients intended to receive at least 4 cycles of doxorubicin or more.
- Patients with performance status <2 according to Eastern Cooperative Oncology Group (ECOG) score.
- Echocardiographic LVEF ≥55%.
- Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).
- Patients with adequate liver function and adequate renal function.
- Signed informed consent to participate in the study.
Критерии исключения
- Age <18 years old and >65 years old.
- Women with history of breast cancer.
- Formerly treated with DOX.
- Patients with a known hypersensitivity to any of the used drugs.
- Treatment with blood thinners for 6 months prior to the screening.
- Treatment with NSAIDS like ketorolac,ibuprofen.
- Patients taking any other cardioprotective medications.
- Pregnancy and breast feeding.
- Alcohol abuse.
- Creatine Clearance < 50 mL/min.
- History of heart failure or LVEF <50%.
- Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
Египет · 1 центр
- Damnhour Oncology Center — Damanhūr
Публикации
- Matboli M, Habib EK, Hussein Mohamed R, Mahran NA, Seleem HS, Nosseir N, Hasanin AH. Pentoxifylline alleviated cardiac injury via modulating the cardiac expression of lncRNA-00654-miR-133a-SOX5 mRNA in the rat model of ischemia-reperfusion. Biomed Pharmacother. 2020 Apr;124:109842. doi: 10.1016/j.biopha.2020.109842. Epub 2020 Jan 20. PMID 31972363
- Dezube BJ, Sherman ML, Fridovich-Keil JL, Allen-Ryan J, Pardee AB. Down-regulation of tumor necrosis factor expression by pentoxifylline in cancer patients: a pilot study. Cancer Immunol Immunother. 1993;36(1):57-60. doi: 10.1007/BF01789132. PMID 7678547
- Fernandes JL, de Oliveira RTD, Mamoni RL, Coelho OR, Nicolau JC, Blotta MHSL, Serrano CV Jr. Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory activity in patients with coronary artery disease--a randomized placebo-controlled study. Atherosclerosis. 2008 Jan;196(1):434-442. doi: 10.1016/j.atherosclerosis.2006.11.032. Epub 2006 Dec 28. PMID 17196208
Идентификаторы
NCT: NCT07137793 · TP/RE/5/25M-006