Blood Flow Restriction Exercise in Patients With Pancreatic, Biliary Tract, and Liver Cancer (PREV-Ex)

NCT05044065 | Completed DMC

• 1 other identifier: PREV-Ex
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 2

Brief Summary

In patients with cancer, resistance training appears to be a safe and effective exercise modality to increase both lean muscle mass and strength, as well as attenuates cancer-related fatigue. It may serve as a feasible intervention in these patients to mitigate cachexia, especially if implemented before the onset of cancer cachexia or in a pre-cachectic state. This study is a multicenter randomized controlled trial that will compare a blood flow restricted resistance training intervention during the pre- (prehabilitation) and post-operative (rehabilitation) phase in patients with pancreatic, biliary tract and liver cancer, versus usual care on skeletal muscle and other health-related outcomes.

Conditions

Pancreatic Cancer; Biliary Tract Cancer; Liver Cancer

Outcome Measures

Primary Outcomes (2)

• Skeletal muscle thickness

  Skeletal muscle thickness (mm) measured through ultrasound

  Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).

• Skeletal muscle cross sectional area

  Skeletal muscle cross sectional area (um2) measured through ultrasound

  Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).

Secondary Outcomes (17)

• Skeletal muscle morphology

  Change from baseline (T0) to: 10-13 weeks (T3).

• Skeletal muscle protein levels

  Change from baseline (T0) to: 10-13 weeks (T3).

• Skeletal muscle metabolism

  Change from baseline (T0) to: 10-13 weeks (T3).

• Body lean mass

  Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).

• Body fat mass

  Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).

Study Arms (2)

Exercise group

EXPERIMENTAL

The experimental group will in addition to standard care receive supervised and home-based exercise training program with a specific focus to induce metabolic stress (blood flow restriction exercise), and protein supplementation to ensure adequate protein intake.

Other: Physical exercise

Usual care

NO INTERVENTION

The control group will in addition to standard care receive protein supplementation to ensure adequate protein intake.

Interventions

Physical exercise OTHER

The intervention group will receive an exercise program consisting of a combination of supervised and home-based exercise with a focus to induce metabolic stress (blood flow restriction exercise) during both a pre- and postoperative period consisting of a total of 6-10 weeks. Protein supplementation will be given to exclude insufficient intake.

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of resectable pancreatic cancer
• Diagnosis of resectable biliary tract cancer (includes cholangiocarcinoma and ampullary cancer)
• Diagnosis of resectable liver cancer
• ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2

You may not qualify if:

• Serious active infection
• Uncontrolled severe pain
• Severe neurologic or cardiac impairment according ACSM criteria
• Uncontrolled severe respiratory insufficiency as determined by the treating clinician
• Any other contraindications for exercise as determined by the treating physician
• Poor Swedish comprehension
• Pregnancy

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• Norwegian School of Sport Sciences: collaborator
• Oslo University Hospital: collaborator

Study Sites (2)

Oslo University Hospital

Oslo, Norway

Location

Karolinska University Hopsital

Stockholm, Sweden

Location

Related Publications (2)

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

  PMID: 39606939 DERIVED

• Anandavadivelan P, Cardinale D, Blomhoff R, Sunde B, Lassen K, Kleive D, Sturesson C, Gilg S, Raastad T, Mijwel S. Blood flow restriction Exercise in the perioperative setting to Prevent loss of muscle mass in patients with pancreatic, biliary tract, and liver cancer: study protocol for the PREV-Ex randomized controlled trial. Trials. 2024 Jun 4;25(1):356. doi: 10.1186/s13063-024-08207-5.

  PMID: 38835083 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Liver Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sara Mijwel, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: September 14, 2021
• Study Start: May 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: March 30, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

NO (1); SE (1)