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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prehabilitation

    Behavioral

    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 support: ensure that the patient's daily energy intake is 20\~25kcal/kg (the target energy reaches 30\~35kcal/kg), and the protein intake is 1.2\~1.5g/(kg·d). (3) Psychological intervention: for patients with mild to moderate anxiety or depression, health education, music therapy and other psychological interventions are carried out. For patients with severe anxiety or depression, psychologists will conduct psychological consultation for patients and provide professional psychological therapy.

  • Routine nursing measures

    Behavioral

    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 support are given, and intravenous or oral nutrition therapy is given to patients who are emaciated and have lost more than 3kg in the past one month. (4) Rehabilitation training: Carry out rehabilitation training education and guidance, including fist exercises, chest expansion exercises, deep breathing, sputum discharge, abdominal muscle strengthening training, etc.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Prehabilitation groupExperimental treatment 2 interventions
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complication Composite Index (CCI) at 30 days postoperatively

Surgical patients were scored based on the severity and number of complications that occurred within 30 days after surgery.

Time frame
30 days after surgery

Secondary outcomes

1

30-Day Postoperative Mortality Rate

The 30-day postoperative mortality rate refers to the proportion of patients who die within 30 days following surgery. This rate was recorded separately for patients in both groups who underwent the surgical procedure.

Time frame
30 days after surgery
2

Six-Minute Walk Distance (6MWD)

In a flat, straight corridor, a 6-minute walk test is conducted to measure the total distance covered on foot.

Time frame
Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively.
3

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score

The EORTC QLQ-C30 questionnaire, comprising 30 items, is meticulously structured into multiple dimensions or domains to provide a comprehensive evaluation of the quality of life in cancer patients. Patients respond to each item based on their personal circumstances, with each item assigned a specific scoring range, typically from 0 to 4 points (or 0 to 3 points, depending on the particular configuration of the item).

Time frame
Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively
4

The Generalized Anxiety Disorder 7-item scale (GAD-7) Score

The Generalized Anxiety Disorder-7 (GAD-7) scale consists of seven items, each of which is associated with symptoms of anxiety. These items include feelings of being nervous, anxious, or on edge; not being able to stop or control worrying; worrying too much about various things; finding it hard to relax; being restless due to unease; becoming easily annoyed or irritable; and feeling afraid as if something awful might happen. Patients respond to each item based on their personal circumstances.

Time frame
Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively

Other outcomes

Sponsors and contacts

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