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

Blood Flow Restriction Exercise in the Perioperative Setting to Prevent the Loss of Muscle Mass in Patients With Pancreatic, Biliary Tract, and Liver Cancer - the PREV-Ex Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Liver Cancer; Biliary Tract Cancer
• Intervention / Treatment: Other: Physical exercise

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; The control group will in addition to standard care receive protein supplementation to ensure adequate protein intake.
Experimental: Exercise group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle morphology	Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies	Change from baseline (T0) to: 10-13 weeks (T3).
Skeletal muscle protein levels	Skeletal muscle protein levels (au) measured through western blot in skeletal muscle biopsies	Change from baseline (T0) to: 10-13 weeks (T3).
Skeletal muscle metabolism	Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies	Change from baseline (T0) to: 10-13 weeks (T3).
Body lean mass	Lean mass (kg) measured through bioimpedance and CT scan	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Body fat mass	Fat mass (kg) measured through bioimpedance and CT scan	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Handgrip strength	Maximal handgrip strength (kg) measured through hand dynamometry	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Health-related quality of life	Disease specific helath related quality of life measured with The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) Summary Score (0-100 points with a higher score indicating a better quality of life)	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
Physical performance	Short Physical Performance Battery (SPPB score points ranging from 0-12 with a higher score indicating a better physical function) measured through handgrip strength test, leg strength test, endurance test	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Cancer-related fatigue	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Fatigue12 (EORTC-QLQ-FA12) Summary Score (0-100 points with a higher score indicating a better quality of life)	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
Nutritional status	Subjective Global Assessment Form scores (score ranging between 7 (normal) and 35 (severely malnourished)	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
Participants' experience of the exercise program	Focus group and individual interviews	3 months
Treatment related complications	days to recover after surgery will be assessed retrospectively through the patients' medical records.	4-7 weeks (T2)
Hospitalization	days of being hospitalized will be assessed retrospectively through the patients' medical records.	5-6 months (T4)
Physical activity	Measured through an activity tracker (hours)	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
Inflammatory markers	Inflammation (au) will be assessed from blood serum and plasma.	Change from baseline (T0) to: 10-13 weeks (T3)
Prognostic markers	Prognostic markers (au) will be assessed from blood serum and plasma.	Change from baseline (T0) to: 10-13 weeks (T3)
Lower limb muscle strength	Maximal leg strength (kg) measured through isometric force measurements	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Oslo University Hospital; Norwegian School of Sport Sciences
• Investigators: Principal Investigator: Sara Mijwel, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: September 5, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Biliary Tract Diseases; Liver Diseases; Biliary Tract Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: PREV-Ex

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No