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

December 24, 2024 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation group
In addition to routine nursing measures, the prehabilitation group underwent prehabilitation measures during the conversion therapy period.
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 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.
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 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.
Placebo Comparator: Control group
During the conversion therapy period, the control group only took routine nursing measures.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
In a flat, straight corridor, a 6-minute walk test is conducted to measure the total distance covered on foot.
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 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).
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 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.
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 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.
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
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.
30 days after surgery
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.
Up to approximately 2 years
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.
Up to approximately 2 years
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).
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2024-994-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prehabilitation

Clinical Trials on Prehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe