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Идёт набор NCT06622954

Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

Без фазы С лечением Cardiotoxicity Breast 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: Protein- and Calorie restriction.
Кому может быть актуально
Состояния в реестре: Cardiotoxicity, Breast Cancer. Базовые параметры: 18 лет — 75 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
Нидерланды
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

Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.

Обзор

The goal of this clinical trial is to compare a dietary intervention with a regular diet in patients with early breast cancer undergoing anthracycline based chemotherapy. The main question it aims to answer is: What are the effects of a short-term diet with 30% caloric and 70% protein restriction (PCR) on cardiotoxicity induced by anthracycline treatment in women with newly diagnosed invasive breast cancer. Researchers will compare the control group with dietary intervention group to see if cardiotoxicity -measured by concentrations of high-sensitivity troponin T (hsTnT) levels- will be different between these two groups.

Вмешательства

  • Другое Protein- and Calorie restriction
    The intervention consists of 30% calorie and 70% protein restriction, based on their daily nutritional intake. The protein and calorie restriction will be given in the form of Scandishake from Nutricia. These are ready available and easy to tailor to the caloric and protein need of each individual study subject.

Первичные конечные точки

  • High-sensitivity troponin T (hsTnT) [Срок оценки: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
Вторичные конечные точки (9)
  • Left ventricular ejection fraction and global longitudinal (LVEF and GLS) [Срок оценки: 6 months and 12 months after start of anthracycline therapy]
  • Creatine kinase [Срок оценки: Bloodsamples will be taken before and 1 hour after each anthracycline cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
  • Effect of dietary intervention on tumor volume/response [Срок оценки: After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks)]
  • Metabolic parameters [Срок оценки: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
  • Other anthracycline-related toxicities [Срок оценки: After each anthracycline based chemotherapy cycle, which is given every 2 weeks. There will be 4 cycles in total.]
  • Effect of dietary intervention on pharmacokinetics of anthracycline [Срок оценки: Bloodsamples will be taken before and 1 hours after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
  • Troponin levels [Срок оценки: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles.]
  • Brain natriuretic peptide (NT-proBNP) [Срок оценки: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
  • Subjective wellbeing [Срок оценки: During each anthracycline chemotherapy cycle. The chemotherapy is given every 2 weeks, in total 4 cycles. Then 6 months and 12 months after start of anthracycline therapy questionnaires will be taken again.]

Критерии участия

Критерии включения

  • women with newly diagnosed triple negative breast cancer with an indication for (neo-)adjuvant ATC-based chemotherapy and of intent to start anticancer treatment;
  • age between 18 and 75 years;
  • written informed consent;
  • body mass index ≥ 19.

Критерии исключения

  • Allergic to any of the ingredients of the diet;
  • Known history of cardiac dysfunction;
  • Severe morbidity with the inability to receive anticancer treatment.
  • Participation in another clinical trial with an intervention arm (database and/or biobank studies excluded);
  • Pregnant women
  • Previous treatment with anthracycline
  • Estrogen receptor positive status

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
Открытое
Основная цель
Профилактика

Центры проведения

Нидерланды · 1 центр
  • Erasmus MC — Rotterdam

Идентификаторы

NCT: NCT06622954 · MEC-2022-0823

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗