---
title: Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients
nct_id: NCT05281211
overall_status: COMPLETED
phase: NA
sponsor: San Camillo Hospital, Rome
study_type: INTERVENTIONAL
primary_condition: Liver Cancer
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05281211.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05281211"
ct_last_update_post_date: 2025-04-18
last_seen_at: "2026-05-12T07:21:22.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients

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

**NCT ID:** [NCT05281211](https://clinicaltrials.gov/study/NCT05281211)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 70
- **Lead Sponsor:** San Camillo Hospital, Rome
- **Conditions:** Liver Cancer, Surgery, Sarcopenia
- **Start Date:** 2022-03-15
- **Completion Date:** 2025-04-15
- **CT.gov Last Update:** 2025-04-18

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Preoperative Nutrition+Exercise** (EXPERIMENTAL) — Preoperative nutrition and exercise pre-habilitation followed by major liver resection.
- **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
- **Exercise** (BEHAVIORAL) — 6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily

## Primary Outcomes

- **Number of participants experiencing 90 day morbidity** _(time frame: 90 days)_ — Patients experiencing complications within 90 days of surgery

## Secondary Outcomes

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

## Locations (2)

- San Camillo Hospital, Rome, Italy, Italy
- San Camillo Forlanini, Roma, RM, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.san camillo hospital|rome|italy|italy` — added _(2026-05-12)_
- `locations.san camillo forlanini|roma|rm|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05281211.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05281211*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*