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NCT Number: NCT06749678

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

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.

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Key information

Conditions

Advanced Hepatocellular Carcinoma (HCC) Prehabilitation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

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.

Primary outcomes

  1. Complication Composite Index (CCI) at 30 days postoperatively

    Time frame: 30 days after surgery

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

Secondary outcomes

  1. 30-Day Postoperative Mortality Rate

    Time frame: 30 days after surgery

    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.

  2. 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.

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

  3. 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 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).

  4. 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 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.

  5. 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 Patient Health Questionnaire-9 (PHQ-9) comprises nine items, each addressing a distinct facet of depressive symptoms. The total score is derived by aggregating the scores from each individual item based on the respondent's chosen answers.

  6. The incidence and severity of postoperative complications.

    Time frame: 30 days after surgery

    During the course of this study and throughout the follow-up period, the severity of postoperative complications in patients who underwent surgery in both groups will be graded and assessed according to the Clavien-Dindo classification system, with all occurrences and degrees of severity of complications being documented.

  7. Adverse Events Related to Conversion Therapy

    Time frame: Up to approximately 2 years

    During the course of this study and throughout the follow-up period, the severity of adverse events will be graded and assessed according to the NCI-CTCAE 5.0. All occurrences of adverse events (AEs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs) will be documented, including their incidence, severity, and correlation with the study medication. Additionally, the number and proportion of subjects who discontinue treatment due to these adverse events will be recorded.

  8. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

    Objective Response Rate (ORR) is a term used in oncology to describe the proportion of patients who experience a complete or partial reduction in their tumor burden in response to treatment. This measure includes both complete responses (CR) and partial responses (PR), and is an important endpoint in assessing the efficacy of cancer therapies.

  9. Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years

    The time from the initiation of the conversion treatment protocol to the occurrence of tumor progression (in any aspect) or death (for any reason).

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Zhang

CONTACT

[email protected]

+86 020 34070701

Yin Long

CONTACT

[email protected]

+86 020 34070701

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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