Liver CancerNEXPREMNCT05281211
Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients
A study testing Nutrition and Exercise in people with Liver Cancer and Surgery, run by San Camillo Hospital, Rome at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Cancer, Surgery, Sarcopenia
- What is being tested?
- Nutrition and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Mar 2022to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Camillo Forlanini
Roma, RM, 00135
San Camillo Hospital
Rome, Italy, 00100
About this study
Official title: Nutrition and EXercise Prehabilitation to Reduce Morbidity (NEXPREM) 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.
- Conditions
- Liver Cancer, Surgery, Sarcopenia
- Being tested
- Nutrition, Exercise
- Keywords
- sarcopenia, liver cancer, liver surgery, hepatectomy
- Medical subject headings
- Liver Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutritionDietary 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
ExerciseBehavioural
6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Nutrition+Exercise | Experimental | Preoperative nutrition and exercise pre-habilitation followed by major liver resection. Receives: Dietary Supplement: Nutrition; Behavioral: Exercise |
| Upfront Surgery | No intervention | Upfront major liver resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing 90 day morbidity
Patients experiencing complications within 90 days of surgery
Measured: 90 days
Secondary outcomes (6)
Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification
Measured: 90 days
Number of participants experiencing 90 days postoperative mortality.
Measured: 90 days
Number of participants being readmitted within 90 days of surgery.
Measured: 90 days
Number of participants being Sarcopenic after 6 weeks of prehabilitation.
Measured: 6 weeks
Number of participants Alive ( Overall Survival)
Measured: 3 years
Number of participants being disease free (Disease free survival)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start15 Mar 2022
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Camillo Hospital, Rome
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giammauro Berardi, San Camillo Hospital, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281211
- Sponsor's protocol ID
- 2022.01
- Acronym
- NEXPREM
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2022
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Berardi G, Cucchetti A, Colasanti M, Angrisani M, Moschetta G, Chiappori D, Marini A, Antonelli G, Ferretti S, Meniconi RL, Guglielmo N, Mariano G, Usai S, Ettorre GM. Prehabilitation With Exercise and Nutrition to Reduce Morbidity of Major Hepatectomy in Patients With Sarcopenia: The PREHEP Randomized Clinical Trial. JAMA Surg. 2025 Oct 1;160(10):1068-1075. doi: 10.1001/jamasurg.2025.3102.
PubMed 40864449
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and EXercise Prehabilitation to Reduce Morbidity (NEXPREM) Following Major Liver Surgery in Sarcopenic Patients
- ClinicalTrials.gov ID
- NCT05281211
- Acronym / sponsor ID
- NEXPREM / 2022.01
- Conditions
- Liver Cancer, Surgery, Sarcopenia
- Keywords
- sarcopenia, liver cancer, liver surgery, hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- San Camillo Hospital, RomeUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Nutrition+Exercise | Experimental | Dietary Supplement: Nutrition, Behavioral: ExercisePreoperative nutrition and exercise pre-habilitation followed by major liver resection. |
| Upfront Surgery | No intervention | –Upfront major liver resection. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition6 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 | Dietary supplement | Preoperative Nutrition+Exercise |
| Exercise6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily | Behavioural | Preoperative Nutrition+Exercise |
Primary outcome
Number of participants experiencing 90 day morbidity
Time frame: 90 days
Patients experiencing complications within 90 days of surgery
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Derived from this study: PubMed 40864449Berardi G, Cucchetti A, Colasanti M, Angrisani M, Moschetta G, Chiappori D, Marini A, Antonelli G, Ferretti S, Meniconi RL, Guglielmo N, Mariano G, Usai S, Ettorre GM. Prehabilitation With Exercise and Nutrition to Reduce Morbidity of Major Hepatectomy in Patients With Sarcopenia: The PREHEP Randomized Clinical Trial. JAMA Surg. 2025 Oct 1;160(10):1068-1075. doi: 10.1001/jamasurg.2025.3102.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Exercise in people with Liver Cancer and Surgery, run by San Camillo Hospital, Rome at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing 90 day morbidity (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.