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NCT07929597
INPACT: Implementation of Nutritional Support and Physical Activity During Cancer Treatment
Conditions: Primary Liver Cancer, Liver Metastasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 103
Sponsor: General Hospital Groeninge
Location: AZ Groeninge Kortrijk
Summary
The INPACT study investigates whether a structured program combining physical exercise, nutritional support, and breathing exercises can improve physical fitness and recovery in patients undergoing liver surgery for cancer.
Approximately 103 adult patients with primary liver cancer or liver metastases who are scheduled for liver resection will participate. Participants will be randomly assigned to one of two groups. The control group will receive usual care, including general advice on maintaining physical activity and a healthy diet. The intervention group will follow a structured prehabilitation and rehabilitation program consisting of supervised and home-based exercise, nutritional support including protein supplementation, and daily breathing exercises.
The program starts approximately four weeks before surgery and continues after surgery during the rehabilitation period. Both groups will undergo assessments of physical fitness, muscle strength, nutritional status, quality of life, and other health outcomes at several time points before and after surgery.
The primary aim of the study is to determine whether the multimodal prehabilitation program improves patients' functional capacity before surgery. The study will also evaluate physical performance, nutritional status, quality of life, postoperative recovery and complications, safety, and adherence to the program.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* Diagnosed with a primary liver cancer or metastases of the liver.
* Patients who need elective surgery (resection)
* Understanding and able to write Dutch or French
* Able and willing to provide written informed consent
Exclusion Criteria:
* Paralytic or immobilised patients who are not able to perform exercises
* Patients scheduled for an ablation
* Kidney dialyse
* Impossibility to wait for 4/5 weeks for elective surgery
* Underlying medical conditions or orthopedic impairments which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
* Logistic reasons preventing the patient to participate in the pre- and rehabilitation program.
* Unable to perform 6 MWT
* Active cardiac ischemia
Source: ClinicalTrials.gov (NCT07929597). StuddyBuddy aggregates publicly available trial information.