Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Unresectable Hepatocellular Carcinoma

Официальное название

Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Patients With Unresectable Hepatocellular Carcinoma: a Prospective, Open, Randomized Controlled Trial

Обзор

This is a prospective, randomised controlled clinical trial to study the impact of prehabilitation on postoperative complications, physical function, quality of life, and short-term survival outcomes in patients with unresectable liver cancer undergoing conversion therapy.

Вмешательства

• Поведенческое Prehabilitation
  In addition to routine nursing measures, the prehabilitation group underwent prehabilitation measures during the conversion therapy period. It includes the following strategies: (1) Exercise: Exercise should be carried out when the patient's condition allows, and the exercise programme should be dynamically adjusted according to the patient's tolerance, and it is advisable to maintain the Borg score between 11\~13 points (i.e., subjectively feel relaxed or a little strained). (2) Nutritional sup
• Поведенческое Routine nursing measures
  Routine nursing measures including: (1) general education: for different patients, cards and manuals were used to focus on the diagnosis and treatment matters such as examination, treatment, surgery and perioperative treatment, so as to alleviate the anxiety and fear of patients and better cooperate with hospital management. (2) Medical optimization: including smoking cessation, alcohol restriction, chronic disease control, etc. (3) Nutritional support: Routine dietary guidance and nutritional s

Первичные конечные точки

• Complication Composite Index (CCI) at 30 days postoperatively [Срок оценки: 30 days after surgery]

Вторичные конечные точки (9)

• 30-Day Postoperative Mortality Rate [Срок оценки: 30 days after surgery]
• Six-Minute Walk Distance (6MWD) [Срок оценки: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively.]
• The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score [Срок оценки: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively]
• The Generalized Anxiety Disorder 7-item scale (GAD-7) Score [Срок оценки: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively]
• The Patient Health Questionnaire-9 (PHQ-9) Depression Scale Score [Срок оценки: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively]
• The incidence and severity of postoperative complications. [Срок оценки: 30 days after surgery]
• Adverse Events Related to Conversion Therapy [Срок оценки: Up to approximately 2 years]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Patients must be aged between 18 and 75 years, inclusive, with no gender restrictions.
• Patients must have an initial diagnosis of unresectable hepatocellular carcinoma (HCC) confirmed by EASL/AASLD diagnostic criteria, pathological histology, or cytology, and must be planned for conversion therapy.
• Patients must have an American Society of Anesthesiologists (ASA) physical status classification of ≤III.
• Patients must be physically capable of participating in exercise training, defined as the ability to walk continuously on flat ground for more than 200 meters without rest and to climb two flights of stairs consecutively without requiring a break.
• Patients must not have any psychiatric disorders, speech impediments, or consciousness disturbances, and must possess adequate comprehension, communication, and literacy skills.
• Patients must voluntarily enroll in the study, be able to provide written informed consent, and be capable of understanding and adhering to the trial protocol and follow-up procedures.

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Критерии исключения

• A known diagnosis of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma (HCC), combined hepatocellular carcinoma, or fibrolamellar carcinoma.
• Presence of extrahepatic metastases or concurrent other malignant tumors.
• Presence of psychiatric disorders or cognitive impairments that would impede compliance with study requirements.
• Unsuitability for participation in exercise training due to skeletal muscle diseases or a history of fracture within the past 6 months.
• Pregnant or breastfeeding women.
• Individuals with severe and irreversible cardiac, pulmonary, or renal organic diseases, or severe anemia, which would make them unsuitable for preoperative rehabilitation programs. -

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

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen Memorial Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06749678 · SYSKY-2024-994-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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