Blood Flow Restriction Exercise in Patients With Pancreatic, Biliary Tract, and Liver Cancer (PREV-Ex)
- Conditions
- Biliary Tract CancerLiver CancerPancreatic Cancer
- Interventions
- Other: Physical exercise
- Registration Number
- NCT05044065
- Lead Sponsor
- Karolinska Institutet
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise group Physical exercise 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.
- Primary Outcome Measures
Name Time Method Skeletal muscle thickness Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). Skeletal muscle thickness (mm) measured through ultrasound
Skeletal muscle cross sectional area Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). Skeletal muscle cross sectional area (um2) measured through ultrasound
- Secondary Outcome Measures
Name Time Method Skeletal muscle morphology Change from baseline (T0) to: 10-13 weeks (T3). Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies
Skeletal muscle metabolism Change from baseline (T0) to: 10-13 weeks (T3). Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies
Prognostic markers Change from baseline (T0) to: 10-13 weeks (T3) Prognostic markers (au) will be assessed from blood serum and plasma.
Handgrip strength Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). Maximal handgrip strength (kg) measured through hand dynamometry
Lower limb muscle strength Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). Maximal leg strength (kg) measured through isometric force measurements
Hospitalization 5-6 months (T4) days of being hospitalized will be assessed retrospectively through the patients' medical records.
Physical activity Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4). Measured through an activity tracker (hours)
Skeletal muscle protein levels Change from baseline (T0) to: 10-13 weeks (T3). Skeletal muscle protein levels (au) measured through western blot in skeletal muscle biopsies
Physical performance Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). 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
Body lean mass Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). Lean mass (kg) measured through bioimpedance and CT scan
Body fat mass Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). Fat mass (kg) measured through bioimpedance and CT scan
Nutritional status Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4). Subjective Global Assessment Form scores (score ranging between 7 (normal) and 35 (severely malnourished)
Participants' experience of the exercise program 3 months Focus group and individual interviews
Treatment related complications 4-7 weeks (T2) days to recover after surgery will be assessed retrospectively through the patients' medical records.
Health-related quality of life Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4). 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)
Cancer-related fatigue Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4). 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)
Inflammatory markers Change from baseline (T0) to: 10-13 weeks (T3) Inflammation (au) will be assessed from blood serum and plasma.
Trial Locations
- Locations (2)
Oslo University Hospital
🇳🇴Oslo, Norway
Karolinska University Hopsital
🇸🇪Stockholm, Sweden