Blood Flow Restriction Exercise in Patients With Pancreatic, Biliary Tract, and Liver Cancer (PRE… (NCT05044065) | Clinical Trial Compass
CompletedNot Applicable
Blood Flow Restriction Exercise in Patients With Pancreatic, Biliary Tract, and Liver Cancer (PREV-Ex)
Norway, Sweden52 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Skeletal muscle thickness
Timeframe: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
2
Skeletal muscle cross sectional area
Timeframe: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).