Идёт набор NCT06938971
Randomized Controlled Trial of the Effects of Combined Resistance and AerobiC Exercise on Health-related Quality of Life in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer (REACH)
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: Exercise training.
- Кому может быть актуально
- Состояния в реестре: Metastatic Colorectal Cancer (mCRC). 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
- Дания
- 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
Effects of Exercise Training on Health-related Quality of Life in Patients With Unresectable Metastatic Colorectal Cancer: A Multi-center Randomized Controlled Trial
Обзор
The primary objective of this trial is to compare the effects of 18 weeks structured exercise training versus on control on healt-related quality of life in patients with mCRC undergoing first-line chemotherapy.
Вмешательства
- Другое Exercise training
Participants allocated to the exercise intervention group will receive standard care plus an exercise intervention. The exercise intervention will consist moderate-to-high intensity supervised and unsupervised home-based exercise training (bicyling, walking, or running) 5 times/week for 18 weeks.
Первичные конечные точки
- Health-related quality of life [Срок оценки: Every 3 weeks from randomization until post-intervention (18 weeks), withdrawal of consent to participate, or death (whichever occurs first)]
Вторичные конечные точки (12)
- Health-related quality of life [Срок оценки: Randomization and 3, 6, 9, 12, 15, and 18 weeks after randomization or until withdrawal of consent to participate, or death (whichever occurs first). Followed-up at 36, 52, 104, and 156 weeks after randomization.]
- Colorectal cancer-specific symptoms [Срок оценки: Randomization and 3, 6, 9, 12, 15, and 18 weeks after randomization or until withdrawal of consent to participate, or death (whichever occurs first). Followed-up at 36, 52, 104, and 156 weeks after randomization.]
- Cancer related fatigue [Срок оценки: Randomization and 3, 6, 9, 12, 15, and 18 weeks after randomization or until withdrawal of consent to participate, or death (whichever occurs first). Followed-up at 36, 52, 104, and 156 weeks after randomization.]
- Patient-reported symptomatic adverse events [Срок оценки: 7 days after every second cycle of treatment, starting from the second cycle. Each cycle is 2-3 weeks, depending on the regimen.]
- Serious adverse events [Срок оценки: From randomization to 20 weeks after randomization]
- Unscheduled hospitalizations [Срок оценки: From randomization to 20 weeks after randomization]
- Dose delays of chemotherapy [Срок оценки: From randomization to 20 weeks after randomization]
- Dose reductions of chemotherapy [Срок оценки: From randomization to 20 weeks after randomization]
- Discontinuation of chemotherapy [Срок оценки: From randomization to 20 weeks after randomization]
- Estimated maximal oxygen uptake [Срок оценки: Randomization, 18 weeks after randomization]
- Estimated maximal oxygen uptake [Срок оценки: Randomization, 18 weeks after randomization]
- Hand-grip strength [Срок оценки: Randomization, 18 weeks after randomization]
Критерии участия
Критерии включения
\- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.
Критерии исключения
- Pregnancy.
- A life expectancy of < 6 months.
- Absolute contraindications to maximal exercise, as per the recommendations by the Danish Society of Cardiology.
- ECOG (Eastern Cooperative Oncology Group) performance status > 2.
- Inability to understand the Danish or English language.
- Engagement in structured moderate-to-high aerobic exercise training for >30 min >1 times/week for the past 3 months at the time of inclusion.
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
- Поддерживающая терапия
Центры проведения
Дания · 4 центра
- Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet — Copenhagen
- Herlev and Gentofte Hospital — Herlev
- North Zealand University Hospital, Hillerød — Hillerød
- Zealand University Hospital, Roskilde — Roskilde
Идентификаторы
NCT: NCT06938971 · Exercise mCRC