An interventional study of Nutrition and Exercise in Liver Cancer, Surgery and Sarcopenia, sponsored by San Camillo Hospital, Rome. Completed at 2 sites in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by San Camillo Hospital, Rome · Not applicable, Interventional, and Prevention
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 70 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →San Camillo Hospital, Rome is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preoperative nutrition and exercise pre-habilitation followed by major liver resection.
Dietary Supplement: Nutrition · Behavioral: Exercise
Upfront major liver resection.
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
6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily
Number of participants experiencing 90 day morbidity
Patients experiencing complications within 90 days of surgery
Time frame: 90 days
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
Plan to share: Yes
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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San Camillo Hospital, Rome