Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases
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: Physical Prehabilitation.
- Кому может быть актуально
- Состояния в реестре: Prehabilitation, Neoadjuvant Therapy, Liver Metastases. 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
- Испания
- 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 →
Официальное название
Multimodal Prehabilitation During Neoadjuvant Chemotherapy in Patients With Colorectal Liver Metastases: a Randomized Controlled Trial
Обзор
Liver resection is the only curative treatment for patients with colorectal liver metastases (CRLM). Most patients undergo chemotherapy (CT) before liver surgery. CT objectively decreases patient functional capacity. It has already been demonstrated that a structured training program carried out during the 4 weeks following CT, while the patient is waiting for liver resection, is able to return the functional capacity to baseline levels. Despite this, multimodal prehabilitation programs (MPP) during preoperative CT have not been evaluated or implemented. The aim of this study is to investigate whether a 16-week MPP applied during and following CT in CRLM patients will result in a significant increase in physical fitness when compared to those that undergo MPP only during the 4-weeks, between the end of CT and liver resection.
Подробное описание
The primary aim of the study is to evaluate the effectiveness of a multimodal prehabilitation program (MPP) in CRLM patients, which will be implemented right through the period of preoperative CT and during the 4-weeks of recovery before liver resection.
MPP will consist of in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.
Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test (6MWT) and will be compared with patients that will follow the MPP only during the 4-weeks before surgery, when preoperative CT has been finished.
Secondary aims include patient reported outcomes measures such as quality of life, postoperative complications, length of hospital stay, 30-day mortality and re-admissions. Protocol feasibility will be evaluated by monitoring all interventions.
Вмешательства
- Поведенческое Physical Prehabilitation
The prehabilitation program consists of the following interventions: in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.
Первичные конечные точки
- Physical Fitness- 6MWT [Срок оценки: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative]
Вторичные конечные точки (12)
- Postoperative complications- Clavien-Dindo classification [Срок оценки: Through study completion, up to one year postoperative]
- Postoperative complications- CCI [Срок оценки: Through study completion, up to one year postoperative]
- Postoperative hospital length of stay [Срок оценки: Postoperative period: assessed up to the first year postoperative]
- Readmissions rate [Срок оценки: Postoperative period: Up to 30 postoperative days]
- Functional capacity- 30CST [Срок оценки: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative]
- Health-related quality of life- SF-36 [Срок оценки: Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative]
- Psychological health- HADS [Срок оценки: Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative]
- Functional capacity- Handgrip strength [Срок оценки: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative]
- Nutritional status- PG-SGA [Срок оценки: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative]
- Nutritional status- BMI [Срок оценки: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative]
- Nutritional status- BIA [Срок оценки: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative]
- Nutritional status- UMA [Срок оценки: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Written informed consent obtained from subject to participate in the study.
Критерии исключения
- Age <18 years
- ASA health class status IV-V
- Mental conditions or disabling orthopedic and neuromuscular disease that prevent physical exercise or may compromise adherence to the program
- Medical contraindication to perform exercise
- Inability to obtain informed consent
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
Испания · 1 центр
- Hospital Universitari de Tarragona Joan XXIII — Tarragona
Идентификаторы
NCT: NCT04520737 · PREHABMET