NCT Number: NCT05044065
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Oslo University Hospital, Oslo, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
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 (um2) measured through ultrasound
Time frame: Change from baseline (T0) to: 10-13 weeks (T3).
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 (au) measured through western blot in skeletal muscle biopsies
Time frame: Change from baseline (T0) to: 10-13 weeks (T3).
Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 3 months
Focus group and individual interviews
Time frame: 4-7 weeks (T2)
days to recover after surgery will be assessed retrospectively through the patients' medical records.
Time frame: 5-6 months (T4)
days of being hospitalized will be assessed retrospectively through the patients' medical records.
Time frame: 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)
Time frame: Change from baseline (T0) to: 10-13 weeks (T3)
Inflammation (au) will be assessed from blood serum and plasma.
Time frame: Change from baseline (T0) to: 10-13 weeks (T3)
Prognostic markers (au) will be assessed from blood serum and plasma.
Karolinska Institutet
Other
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
Acronym: PREV-Ex
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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