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

Primary Purpose

Liver Cancer, Surgery, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nutrition
Exercise
Sponsored by
San Camillo Hospital, Rome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cancer focused on measuring sarcopenia, liver cancer, liver surgery, hepatectomy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Camillo ForlaniniRecruiting
  • San Camillo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preoperative Nutrition+Exercise

Upfront Surgery

Arm Description

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

Upfront major liver resection.

Outcomes

Primary Outcome Measures

Number of participants experiencing 90 day morbidity
Patients experiencing complications within 90 days of surgery

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2022
Last Updated
May 15, 2022
Sponsor
San Camillo Hospital, Rome
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1. Study Identification

Unique Protocol Identification Number
NCT05281211
Brief Title
Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients
Acronym
NEXPREM
Official Title
Nutrition and EXercise Prehabilitation to Reduce Morbidity (NEXPREM) Following Major Liver Surgery in Sarcopenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Camillo Hospital, Rome

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Surgery, Sarcopenia
Keywords
sarcopenia, liver cancer, liver surgery, hepatectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative Nutrition+Exercise
Arm Type
Experimental
Arm Description
Preoperative nutrition and exercise pre-habilitation followed by major liver resection.
Arm Title
Upfront Surgery
Arm Type
No Intervention
Arm Description
Upfront major liver resection.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily
Primary Outcome Measure Information:
Title
Number of participants experiencing 90 day morbidity
Description
Patients experiencing complications within 90 days of surgery
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification
Time Frame
90 days
Title
Number of participants experiencing 90 days postoperative mortality.
Time Frame
90 days
Title
Number of participants being readmitted within 90 days of surgery.
Time Frame
90 days
Title
Number of participants being Sarcopenic after 6 weeks of prehabilitation.
Time Frame
6 weeks
Title
Number of participants Alive ( Overall Survival)
Time Frame
3 years
Title
Number of participants being disease free (Disease free survival)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giammauro BERARDI
Phone
0658705816
Email
gberardi1@gmail.com
Facility Information:
Facility Name
San Camillo Forlanini
City
Roma
State/Province
RM
ZIP/Postal Code
00135
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giammauro BERARDI
Phone
0658704816
Email
gberardi1@gmail.com
Facility Name
San Camillo Hospital
City
Rome
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giammauro Berardi, MD
Phone
0658704816
Email
gberardi1@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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