To Evaluate the Clinical Efficacy of Probiotics in Patients With the 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: Probiotic, Placebo.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer. Базовые параметры: 20 лет — 80 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
- Тайвань
- 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
To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer
Обзор
Chemotherapy-associated side-effects would affect therapeutic effect, quality of life, and cause permanent harm to breast cancer patients. This study is designed to explore after consumption of probiotics of lactobacillus composite strain powder sachets for 6 months in breast cancer chemotherapy, and whether the improvement of meliorate the side effects, further assists patients completing the chemotherapy.
Подробное описание
In 2020, the incidence rate of women's breast cancer in Taiwan was up to 82.1% . The death rate increased to 16%; in 2021, the ranking rose to no.3, and the death rate grew up to 24.6%. In the decades, breast cancer gradually becomes the dominant malignant women's cancer in Taiwan. Besides the lumpectomy, chemotherapy is one of the dominant and important treatments for breast cancer. Beyond the effects of chemotherapy, several side effects rise up. The most common chemotherapy are anthracyclin drugs (doxorubicin and epirubicin) and taxane (docetaxel and paclitaxel ). There are common side effects including neutropenia, hair loss, vomiting, diarrhea, stomatitis, mucositis, peripheral neuropathy, dermatitis, nephrotoxicity, and hepatotoxicity. Currently, most treatments for chemotherapy-induced side effects are symptomatic treatment, but there is no good solution to prevent it.
Вмешательства
- Пищевая добавка Probiotic
Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive). - Другое Placebo
Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
Первичные конечные точки
- Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks [Срок оценки: 24 weeks]
Вторичные конечные точки (12)
- Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks [Срок оценки: 24 weeks]
- Variability in BMI (Body Mass Index) [Срок оценки: 24 weeks]
- Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks [Срок оценки: 12 weeks]
- Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks [Срок оценки: 24 weeks]
- Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks [Срок оценки: 12 weeks]
- Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks [Срок оценки: 24 weeks]
- Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks [Срок оценки: 12 weeks]
- Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks [Срок оценки: 24 weeks]
- Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks [Срок оценки: 12 weeks]
- Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks [Срок оценки: 24 weeks]
- Change from baseline in gut microbiome at 12 weeks [Срок оценки: 12 weeks]
- Change from baseline in gut microbiome at 24 weeks [Срок оценки: 24 weeks]
Критерии участия
Критерии включения
- Stage I-III breast patients using anthracycline-based and taxane-based chemotherapy (not limited before or after chemotherapy/surgery)
- BMI > 18 kg/m\^2
- Age between 20 and 80 years old
- Patients judged by physicians to participate in this trial and who are willing
Критерии исключения
- Pregnant or lactating female patients
- Patients with bariatric surgery, gastrointestinal resections, Crohn's disease, celiac disease
- BMI < 18 kg/m\^2
- Patient who have severe allergy to soybeans or peanuts
- Those who are under 20 years old or over 80 years old
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
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Тайвань · 1 центр
- Mackay Memorial Hospital — Taipei
Идентификаторы
NCT: NCT06039644 · BC2023