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NCT Number: NCT05281211

Nutrition and Exercise Prehabilitation to Reduce Morbidity 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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Camillo Hospital, Rome, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Number of participants experiencing 90 day morbidity

    Time frame: 90 days

    Patients experiencing complications within 90 days of surgery

Secondary outcomes

  1. Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification

    Time frame: 90 days

  2. Number of participants experiencing 90 days postoperative mortality.

    Time frame: 90 days

  3. Number of participants being readmitted within 90 days of surgery.

    Time frame: 90 days

  4. Number of participants being Sarcopenic after 6 weeks of prehabilitation.

    Time frame: 6 weeks

  5. Number of participants Alive ( Overall Survival)

    Time frame: 3 years

  6. Number of participants being disease free (Disease free survival)

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

San Camillo Hospital, Rome

Other

Registry information

Official study title

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

Acronym: NEXPREM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2022
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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