Not yet recruiting NCT06749678
Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Unresectable Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prehabilitation, Routine nursing measures.
- Who it may be relevant to
- Registry conditions: Advanced Hepatocellular Carcinoma (HCC), Prehabilitation. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Patients With Unresectable Hepatocellular Carcinoma: a Prospective, Open, Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral 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 - Behavioral 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
Primary outcome measures
- Complication Composite Index (CCI) at 30 days postoperatively [Time frame: 30 days after surgery]
Secondary outcome measures (9)
- 30-Day Postoperative Mortality Rate [Time frame: 30 days after surgery]
- Six-Minute Walk Distance (6MWD) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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. [Time frame: 30 days after surgery]
- Adverse Events Related to Conversion Therapy [Time frame: Up to approximately 2 years]
- Objective Response Rate (ORR) [Time frame: Up to approximately 2 years]
- Progression-Free Survival (PFS) [Time frame: Up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- 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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Exclusion criteria
- 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. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital — Guangzhou
Identifiers
NCT: NCT06749678 · SYSKY-2024-994-03