Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Unresectable Hepatocellular Carcinoma
NCT ID: NCT06749678
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
84 participants
INTERVENTIONAL
2025-01-01
2027-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prehabilitation group
In addition to routine nursing measures, the prehabilitation group underwent prehabilitation measures during the conversion therapy period.
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.
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.
Control group
During the conversion therapy period, the control group only took routine nursing measures.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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. -
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Locations
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Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Lei Zhang
Role: primary
Other Identifiers
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SYSKY-2024-994-03
Identifier Type: -
Identifier Source: org_study_id