An interventional study of Multimodal Prehabilitation and Rehabilitation Program and Usual Care in Primary Liver Cancer and Liver Metastasis, sponsored by General Hospital Groeninge. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by General Hospital Groeninge · Not applicable, Interventional, and Supportive care
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.
INPACT (Implementation of Nutritional Support and Physical Activity during Cancer Treatment) is a prospective randomized controlled trial investigating the role of multimodal prehabilitation in patients undergoing oncological liver resection for primary liver cancer or liver metastases.
Patients undergoing liver surgery frequently present with impaired physical fitness, nutritional deficits, reduced physiological reserve, and the consequences of previous cancer treatments. These factors may negatively affect their ability to tolerate major surgery and recover adequately afterwards. Functional capacity has been identified as an important indicator of physiological reserve and has been associated with postoperative outcomes in surgical oncology populations.
Prehabilitation aims to optimize patients before surgery by improving their physical condition and nutritional status during the period between diagnosis and surgery. This interval represents a potential window of opportunity to enhance a patient's resilience to surgical stress. Previous studies have shown that multimodal prehabilitation programs combining exercise training, nutritional support, and psychological or respiratory interventions may improve preoperative functional capacity and patient wellbeing. However, evidence remains limited in patients undergoing oncological liver resection, particularly in highly optimized healthcare settings where enhanced recovery pathways and minimally invasive surgical techniques are already routinely implemented.
The INPACT study evaluates a multimodal program consisting of structured exercise training, nutritional support, and breathing exercises initiated before surgery and continued during postoperative rehabilitation. The study aims to determine whether this approach can improve patients' functional capacity before surgery and contribute to improved recovery following liver resection.
In addition to evaluating the direct effects of prehabilitation on functional capacity, the study will provide further insight into nutritional status, patient-reported outcomes, postoperative recovery, healthcare utilization, biological markers of inflammation and recovery, and long-term oncological outcomes. The results may contribute to the development and implementation of evidence-based prehabilitation programs for patients undergoing major oncological surgery.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 103 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →General Hospital Groeninge is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention group will follow a structured multimodal prehabilitation and rehabilitation program consisting of physical exercise, nutritional support with protein supplementation, and daily breathing exercises. The prehabilitation program starts approximately four weeks before surgery. After surgery, the program is gradually resumed during the rehabilitation phase according to the patient's recovery and individual capacity.
Behavioral: Multimodal Prehabilitation and Rehabilitation Program
Participants in the control group will receive usual care. Patients are encouraged to remain physically active and receive general advice regarding physical activity and healthy nutrition, but no individualized structured exercise and nutritional program is prescribed or monitored.
Other: Usual Care
The multimodal program combines physical exercise, nutritional support, and breathing exercises. During the approximately four-week preoperative period, participants perform two supervised in-hospital exercise sessions per week and three home-based cycling sessions per week. Participants also receive nutritional support including daily protein supplementation and perform daily breathing exercises using a Moonbird device. After surgery, the program is gradually resumed during the rehabilitation phase according to the patient's postoperative recovery and individual capacity.
Participants receive usual care for patients undergoing oncologic liver surgery. As part of usual care, patients are encouraged to remain physically active and receive general advice regarding physical activity and healthy nutrition. No individualized structured prehabilitation and rehabilitation program is prescribed or monitored.
Functional capacity measured by the 6-Minute Walk Test (6MWT)
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT). The distance walked during 6 minutes will be recorded in meters. The 6MWT distance at the preoperative assessment will be compared between the multimodal prehabilitation group and the usual care group.
Time frame: 4 weeks after baseline, prior to surgery
Change in functional capacity measured by the 6-Minute Walk Test (6MWT)
Change in distance walked during the 6-Minute Walk Test (6MWT), expressed in meters, will be assessed and compared between the intervention and usual care groups.
Time frame: From baseline to 4 weeks after baseline and 6 weeks after surgery
Cardiorespiratory fitness measured by VO2max
Cardiorespiratory fitness will be assessed using cardiopulmonary exercise testing (CPET). Maximum oxygen uptake (VO2max) will be compared between the intervention and usual care groups.
Time frame: Baseline, 4 weeks after baseline, and 6 weeks after surgery
Handgrip strength
Upper-body muscle strength will be assessed using a handgrip strength test and expressed in kilograms. Results will be compared between groups over time.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Lower-extremity muscle strength measured by Biodex
Lower-extremity muscle strength will be assessed using Biodex dynamometry and compared between the intervention and usual care groups over time.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Single-leg calf raise performance
Lower-extremity muscle performance will be assessed using the single-leg calf raise test and compared between groups over time.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Sit-to-stand performance
Functional lower-extremity performance will be assessed using the Sit-to-Stand Test. Participants are instructed to stand up and sit down 10 times as quickly as possible from a chair without using their hands. The outcome measure is the time required to complete 10 repetitions, expressed in seconds. Scores range from 0 seconds to no predefined maximum value. Lower completion times indicate better lower-extremity functional performance, whereas higher completion times indicate worse functional performance.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Health-related quality of life measured by EORTC QLQ-C30
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual. For the Global Health Status/Quality of Life scale and functional scales, higher scores indicate better quality of life and functioning. For symptom scales and single-item symptom measures, higher scores indicate greater symptom burden and worse quality of life.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Health-related quality of life measured by EQ-5D
Health-related quality of life and general health status will be assessed using the EuroQol 5-Dimension Questionnaire (EQ-5D). The EQ-5D descriptive system generates an index score ranging from less than 0 (health states considered worse than death) to 1.0 (perfect health), with higher scores indicating better health-related quality of life. The EQ-5D also includes a Visual Analogue Scale (EQ VAS), ranging from 0 to 100, where higher scores indicate better perceived health status.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Postoperative complications measured by the Comprehensive Complication Index (CCI)
Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI), which summarizes all postoperative complications weighted according to their severity. The CCI score ranges from 0 to 100, where 0 indicates no postoperative complications and 100 indicates death. Higher scores indicate a greater overall burden of postoperative complications and therefore a worse postoperative outcome.
Time frame: within 90 days after surgery
Length of hospital stay
Length of postoperative hospital stay will be recorded as the number of days from the date of surgery until discharge from the hospital and compared between the intervention and usual care groups.
Time frame: From the date of surgery until hospital discharge, assessed up to 90 days after surgery
Nutritional status measured by PG-SGA SF
Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF). The total PG-SGA SF score ranges from 0 to 36, with higher scores indicating a greater risk of malnutrition and a worse nutritional status. Lower scores indicate a better nutritional status.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Compliance with nutritional supplementation
Compliance with the prescribed nutritional supplementation will be assessed using the patient diary in participants allocated to the intervention group.
Time frame: From baseline until 6 weeks after surgery
Safety assessed by adverse events and serious adverse events
Safety will be assessed by recording the total number of adverse events (AEs) and serious adverse events (SAEs), as well as the proportion of participants experiencing an AE or SAE.
Time frame: From baseline until 6 weeks after surgery
Compliance with the exercise program
Adherence to the exercise program will be assessed using the patient exercise diary and expressed as the percentage of prescribed exercise sessions completed. Perceived exertion during training will be assessed using the Borg Rating of Perceived Exertion Scale. The Borg Rating of Perceived Exertion Scale ranges from 6 to 20, with higher scores indicating greater perceived exercise intensity and exertion.
Time frame: Throughout the prehabilitation and rehabilitation program, up to 6 weeks after surgery
Three-year disease-free survival
Disease-free survival is defined as the time from surgery to the first occurrence of disease recurrence. Participants without recurrence will be censored at the time of last follow-up.
Time frame: 3 years after surgery
Three-year overall survival
Overall survival is defined as the time from surgery to death. Participants who are alive will be censored at the time of last follow-up.
Time frame: 3 years after surgery
Health-economic impact of the multimodal program (sing EQ-5D utility scores and Quality-Adjusted Life Years (QALYs)
An exploratory health-economic analysis will be performed using EQ-5D utility scores to estimate Quality-Adjusted Life Years (QALYs). The health-economic impact of the multimodal prehabilitation and rehabilitation program will be evaluated by comparing QALYs and healthcare resource utilization between the intervention and usual care groups.
Time frame: Through study completion, up to 6 weeks after surgery
Patient perceptions of breathing exercises
Participants' perceptions and experiences regarding the breathing exercises using the Moonbird device will be explored through semi-structured interviews. Responses will undergo qualitative thematic analysis. This is a qualitative outcome measure and no numerical score will be calculated.
Time frame: At or after 6 weeks after surgery
C-Reactive Protein (CRP)
Serum C-reactive protein (CRP) concentration (mg/L) will be measured and compared between groups. Higher values indicate a greater systemic inflammatory response.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
White Blood Cell Count (WBC)
White blood cell count (WBC) (×10\^9/L) be measured and compared between groups. Higher values indicate a greater inflammatory response.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Interleukin-6 (IL-6)
Plasma interleukin-6 (IL-6) (pg/mL) will be measured and compared between groups. Higher values indicate a greater inflammatory response.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Interleukin-8 (IL-8)
Plasma interleukin-8 (IL-8) concentration (pg/mL) will be measured and compared between groups.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Interleukin-10 (IL-10)
Plasma interleukin-10 (IL-10) concentration (pg/mL) will be measured and compared between groups.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Tumor Necrosis Factor Alpha (TNF-α)
Tumor Necrosis Factor Alpha (TNF-α) concentration (pg/mL) will be measured and compared between groups.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Troponin
Serum troponin concentration (ng/L) will be measured and compared between groups.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Ferritin
Serum ferritin concentration (µg/L) will be measured and compared between groups.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
Albumin
Serum albumin concentration (g/L) will be measured and compared between groups. Lower values may indicate impaired nutritional status.
Time frame: Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
Of 360 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 17 months is below that.
Counting every sponsor, half of 384 studies reached it within 47 months; a quarter within 23 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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General Hospital Groeninge