Pancreatic CancerPREV-ExNCT05044065
Blood Flow Restriction Exercise in Patients With Pancreatic, Biliary Tract, and Liver Cancer (PREV-Ex)
A study testing Physical exercise in people with Pancreatic Cancer and Biliary Tract Cancer, run by Karolinska Institutet at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Biliary Tract Cancer, Liver Cancer
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2022to 30 Mar 2025
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer, Biliary Tract Cancer, Liver Cancer
- Being tested
- Physical exercise
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical exercise |
| Usual care | No intervention | The control group will in addition to standard care receive protein supplementation to ensure adequate protein intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle thickness
Skeletal muscle thickness (mm) measured through ultrasound
Measured: 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
Measured: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Secondary outcomes (19)
Skeletal muscle morphology
Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies
Measured: 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
Measured: Change from baseline (T0) to: 10-13 weeks (T3).
Skeletal muscle metabolism
Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies
Measured: Change from baseline (T0) to: 10-13 weeks (T3).
Body fat mass
Fat mass (kg) measured through bioimpedance, Dxa and CT scan
Measured: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Body lean mass
Lean mass (kg) measured through bioimpedance, Dxa and CT scan
Measured: 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
Measured: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Lower limb muscle strength
Maximal leg strength (kg) measured through isometric force measurements
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 3 months
Treatment related complications
days to recover after surgery will be assessed retrospectively through the patients' medical records.
Measured: 4-7 weeks (T2)
Hospitalization
days of being hospitalized will be assessed retrospectively through the patients' medical records.
Measured: 5-6 months (T4)
Physical activity
Measured through an activity tracker (hours)
Measured: 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.
Measured: Change from baseline (T0) to: 10-13 weeks (T3)
Prognostic markers
Prognostic markers (au) will be assessed from blood serum and plasma.
Measured: Change from baseline (T0) to: 10-13 weeks (T3)
Visceral body fat mass
Visceral body fat mass (kg) measured through bioimpedance, Dxa and CT scan
Measured: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Upper limb muscle strength
Maximal leg strength (kg) measured through isometric force measurements
Measured: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 May 2022
- Primary completion30 Oct 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Norwegian School of Sport Sciences, Oslo University Hospital
- Responsible party
- Principal investigator, Sara Mijwel, Karolinska Institutet
- Investigators
- Sara Mijwel, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044065
- Sponsor's protocol ID
- PREV-Ex
- Acronym
- PREV-Ex
- Status last verified
- Oct 2026
- First submitted
- 16 Aug 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39606939Anandavadivelan 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.
PubMed 38835083