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

Sponsor

San Camillo Hospital, Rome (Other)

Overall Status

Recruiting

CT.gov ID

NCT05281211

Collaborator

(none)

Enrollment

Locations

Arms

23.1

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer Surgery Sarcopenia	Dietary Supplement: Nutrition Behavioral: Exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Feb 15, 2024

Anticipated Study Completion Date :

Feb 15, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of participants experiencing 90 day morbidity [90 days]
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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Camillo Forlanini	Roma	RM	Italy	00135
2	San Camillo Hospital	Rome		Italy	00100

Sponsors and Collaborators

San Camillo Hospital, Rome

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giammauro Berardi, Principal Investigator, San Camillo Hospital, Rome

ClinicalTrials.gov Identifier:

NCT05281211

Other Study ID Numbers:

2022.01

First Posted:

Mar 16, 2022

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Giammauro Berardi, Principal Investigator, San Camillo Hospital, Rome

Additional relevant MeSH terms:

Liver Neoplasms

Sarcopenia

Study Results

No Results Posted as of May 17, 2022