Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients (NEXPREM)

Nutrition and EXercise Prehabilitation to Reduce Morbidity (NEXPREM) Following Major Liver Surgery in Sarcopenic Patients

NEXPREM is a single-center non-blinded randomized controlled trial investigating preoperative exercise and nutrition for sarcopenic patients in major hepatic surgery for liver malignancies. Patients with sarcopenia undergoing major hepatectomies have high rates of postoperative complications. Previous studies have demonstrated that preoperative rehabilitation with exercise and nutrition may help reduce the negative impact of sarcopenia. The investigator's hypothesis is that preoperative nutrition and exercise may reduce complications in sarcopenic patients undergoing major hepatectomies. Sarcopenic patients at diagnosis will be randomized in Group A undergoing upfront surgery and Group B undergoing preoperative rehabilitation. Outcome will be overall 90 day morbidity.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Surgery; Liver Cancer
• Intervention / Treatment: Dietary supplement: Nutrition; Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00100
    • San Camillo Hospital
  • RM
    • Roma, RM, Italy, 00135
      • San Camillo Forlanini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18.
• Sarcopenic patients diagnosed by both qualitative and quantitative analysis.
• Patients with primary or secondary liver malignancies.
• Patients undergoing major liver resections intended as 3 or more contiguous segments
• Patients undergoing open, laparoscopic, or robotic resections.

Exclusion Criteria:

• Minor liver resections intended as less than 3 contiguous segments.
• Patients with intrahepatic, hilar, or extrahepatic cholangiocarcinomas.
• Patients with liver tumors for whom 6 weeks interval from diagnosis to surgery could not be waited (i.e., large HCCs on healthy livers not requiring preoperative portal vein occlusion, CRLM without preoperative administration of anti-VEGF drug who therefore do not require 6 weeks of chemotherapy washout)
• Patients with benign liver lesions.
• Patients undergoing extrahepatic liver resections.
• Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) procedure.
• Patients with physical disabilities, unable to exercise.
• Patients with inadequate kidney function.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative Nutrition+Exercise; Preoperative nutrition and exercise pre-habilitation followed by major liver resection.	Dietary supplement: Nutrition; 6 weeks nutrition implementation in the form of branched chain amino acids and immune-system boosters twice daily for 4 weeks and once daily for 2 weeks; Behavioral: Exercise; 6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily
No Intervention: Upfront Surgery; Upfront major liver resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants experiencing 90 day morbidity	Patients experiencing complications within 90 days of surgery	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification	90 days
Number of participants experiencing 90 days postoperative mortality.	90 days
Number of participants being readmitted within 90 days of surgery.	90 days
Number of participants being Sarcopenic after 6 weeks of prehabilitation.	6 weeks
Number of participants Alive ( Overall Survival)	3 years
Number of participants being disease free (Disease free survival)	3 years

Collaborators and Investigators

• Sponsor: San Camillo Hospital, Rome

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: February 12, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: sarcopenia; liver cancer; hepatectomy; liver surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Muscular Atrophy; Atrophy; Liver Neoplasms; Sarcopenia
• Other Study ID Numbers: 2022.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No