Biliary Tract Cancer, Liver Cancer, Pancreatic Cancer
Conditions
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.
Interventions
OTHERPhysical exercise
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.
Sponsors
Karolinska University Hospital
Norwegian School of Sport Sciences
Oslo University Hospital
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle metabolism | Change from baseline (T0) to: 10-13 weeks (T3). | Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies |
| 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 |
| 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 |
| 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) |
| 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 |
| Skeletal muscle morphology | Change from baseline (T0) to: 10-13 weeks (T3). | Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies |
| 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. |
| 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) |
| Inflammatory markers | Change from baseline (T0) to: 10-13 weeks (T3) | Inflammation (au) will be assessed from blood serum and plasma. |
| Prognostic markers | Change from baseline (T0) to: 10-13 weeks (T3) | Prognostic markers (au) will be assessed from blood serum and plasma. |
| 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) |
| 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 |
Countries
Norway, Sweden
Outcome results
None listed