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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Advanced Hepatocellular Carcinoma (HCC); Prehabilitation

Treatments: Behavioral: Prehabilitation; Behavioral: Routine nursing measures

Study type: Interventional

Funder types: Other

Identifiers

NCT06749678

SYSKY-2024-994-03

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be aged between 18 and 75 years, inclusive, with no gender restrictions.

2. 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.

3. Patients must have an American Society of Anesthesiologists (ASA) physical status classification of ≤III.

4. 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.

5. Patients must not have any psychiatric disorders, speech impediments, or consciousness disturbances, and must possess adequate comprehension, communication, and literacy skills.

6. 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups, including a placebo group

Prehabilitation group

Experimental group

Description:

In addition to routine nursing measures, the prehabilitation group underwent prehabilitation measures during the conversion therapy period.

Treatment:

Behavioral: Routine nursing measures

Behavioral: Prehabilitation

Control group

Placebo Comparator group

Description:

During the conversion therapy period, the control group only took routine nursing measures.

Treatment:

Behavioral: Routine nursing measures