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

NCT06749678 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2024-994-03
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Hepatocellular Carcinoma (HCC); Prehabilitation

Keywords

unresectable hepatocellular carcinoma; prehabilitation; conversion therapy

Outcome Measures

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.

  30 days after surgery

Secondary Outcomes (9)

• 30-Day Postoperative Mortality Rate

  30 days after surgery

• Six-Minute Walk Distance (6MWD)

  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

  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

  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

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

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

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

Behavioral: Prehabilitation; Behavioral: Routine nursing measures

Control group

PLACEBO COMPARATOR

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

Behavioral: Routine nursing measures

Interventions

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.

Prehabilitation group

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.

Control group; Prehabilitation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Lei Zhang

CONTACT

+86 020 34070701; zhangl9@mail.sysu.edu.cn

Yin Long

CONTACT

+86 020 34070701; longyin318@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)