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

NCT05281211 | Completed

• 1 other identifier: 2022.01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Liver Cancer; Surgery; Sarcopenia

Keywords

sarcopenia; liver cancer; liver surgery; hepatectomy

Outcome Measures

Primary Outcomes (1)

• Number of participants experiencing 90 day morbidity

  Patients experiencing complications within 90 days of surgery

  90 days

Secondary Outcomes (6)

• 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

Study Arms (2)

Preoperative Nutrition+Exercise

EXPERIMENTAL

Preoperative nutrition and exercise pre-habilitation followed by major liver resection.

Dietary Supplement: Nutrition; Behavioral: Exercise

Upfront Surgery

NO INTERVENTION

Upfront major liver resection.

Interventions

Nutrition DIETARY_SUPPLEMENT

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

Preoperative Nutrition+Exercise

Exercise BEHAVIORAL

6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily

Preoperative Nutrition+Exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Camillo Hospital, Rome: lead

Study Sites (2)

San Camillo Hospital

Rome, Italy, 00100, Italy

Location

San Camillo Forlanini

Roma, RM, 00135, Italy

Location

Related Publications (1)

• Berardi G, Cucchetti A, Colasanti M, Angrisani M, Moschetta G, Chiappori D, Marini A, Antonelli G, Ferretti S, Meniconi RL, Guglielmo N, Mariano G, Usai S, Ettorre GM. Prehabilitation With Exercise and Nutrition to Reduce Morbidity of Major Hepatectomy in Patients With Sarcopenia: The PREHEP Randomized Clinical Trial. JAMA Surg. 2025 Oct 1;160(10):1068-1075. doi: 10.1001/jamasurg.2025.3102.

  PMID: 40864449 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Sarcopenia

Interventions

Nutritional Status; Exercise

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: March 16, 2022
• Study Start: March 15, 2022
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (2)