Clinical trial NCT05044065: Blood Flow Restriction Exercise in Patients With Pancreatic, Biliary Tract, and Liver Cancer (PREV-Ex)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Biliary Tract Cancer
Liver Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Norwegian School of Sport Sciences
name: Oslo University Hospital
First posted: 2021-09-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Skeletal muscle thickness
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
measure: Skeletal muscle cross sectional area
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Secondary outcomes:
measure: Skeletal muscle morphology
timeFrame: Change from baseline (T0) to: 10-13 weeks (T3).
measure: Skeletal muscle protein levels
timeFrame: Change from baseline (T0) to: 10-13 weeks (T3).
measure: Skeletal muscle metabolism
timeFrame: Change from baseline (T0) to: 10-13 weeks (T3).
measure: Body lean mass
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
measure: Body fat mass
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
measure: Handgrip strength
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
measure: Lower limb muscle strength
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
measure: Health-related quality of life
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
measure: Physical performance
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
measure: Cancer-related fatigue
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
measure: Nutritional status
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
measure: Participants' experience of the exercise program
timeFrame: 3 months
measure: Treatment related complications
timeFrame: 4-7 weeks (T2)
measure: Hospitalization
timeFrame: 5-6 months (T4)
measure: Physical activity
timeFrame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
measure: Inflammatory markers
timeFrame: Change from baseline (T0) to: 10-13 weeks (T3)
measure: Prognostic markers
timeFrame: Change from baseline (T0) to: 10-13 weeks (T3)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hopsital
Study officials:
affiliation: Karolinska Institutet
name: Sara Mijwel, PhD
role: PRINCIPAL_INVESTIGATOR
References: