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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
52
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.
Oslo University Hospital
Oslo, Norway
Karolinska University Hopsital
Stockholm, Sweden
Skeletal muscle thickness
Skeletal muscle thickness (mm) measured through ultrasound
Time frame: 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
Time frame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Skeletal muscle morphology
Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies
Time frame: 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
Time frame: Change from baseline (T0) to: 10-13 weeks (T3).
Skeletal muscle metabolism
Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies
Time frame: Change from baseline (T0) to: 10-13 weeks (T3).
Body lean mass
Lean mass (kg) measured through bioimpedance and CT scan
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 3 months
Treatment related complications
days to recover after surgery will be assessed retrospectively through the patients' medical records.
Time frame: 4-7 weeks (T2)
Hospitalization
days of being hospitalized will be assessed retrospectively through the patients' medical records.
Time frame: 5-6 months (T4)
Physical activity
Measured through an activity tracker (hours)
Time frame: 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.
Time frame: Change from baseline (T0) to: 10-13 weeks (T3)
Prognostic markers
Prognostic markers (au) will be assessed from blood serum and plasma.
Time frame: Change from baseline (T0) to: 10-13 weeks (T3)
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