PREV-Ex: Metabolic Stress-induced Exercise to Prevent Loss of Muscle Mass in Patients With Pancreatic and Biliary Tract Cancer
Study Details
Study Description
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 metabolic-stress induced resistance training intervention during the pre- (prehabilitation) and post-operative (rehabilitation) phase in patients with pancreatic and biliary tract cancer, versus usual care on skeletal muscle and other health-related outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise group 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, and protein supplementation to ensure adequate protein intake. |
Other: Physical 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 during both a pre- and postoperative period consisting of a total of 5-6 weeks. Protein supplementation will be given to exclude insufficient intake.
|
| No Intervention: Usual care The control group will in addition to standard care receive protein supplementation to ensure adequate protein intake. |
Outcome Measures
Primary Outcome Measures
- Skeletal muscle thickness [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Skeletal muscle thickness (mm) measured through ultrasound
- Skeletal muscle cross sectional area [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Skeletal muscle cross sectional area (um2) measured through ultrasound
Secondary Outcome Measures
- Skeletal muscle morphology [Change from baseline to: 2 weeks, 8 weeks]
Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies
- Skeletal muscle protein levels [Change from baseline to: 2 weeks, 8 weeks]
Skeletal muscle protein levels (au) measured through western blot in skeletal muscle biopsies
- Skeletal muscle metabolism [Change from baseline to: 2 weeks, 8 weeks]
Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies
- Body lean mass [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Lean mass (kg) measured through bioimpedance and CT scan
- Body fat mass [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Fat mass (kg) measured through bioimpedance and CT scan
- Handgrip strength [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Maximal handgrip strength (kg) measured through hand dynamometry
- Lower limb muscle strength [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Maximal led strength (kg) measured through isometric force measurements
- Health-related quality of life [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
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 to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
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
- Cancer-related fatigue [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
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)
- Nutritional status [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Subjective Global Assessment Form scores (score ranging between 7 (normal) and 35 (severely malnourished)
- Participants' experience of the exercise program [8 weeks]
Focus group interviews
- Treatment related complications [4 weeks]
days to recover after surgery
- Treatment related complications [8 weeks]
days to recover after surgery
- Treatment related complications [16 weeks]
days to recover after surgery
- Hospitalization [4 weeks]
days of being hospitalized
- Hospitalization [8 weeks]
days of being hospitalized
- Hospitalization [16 weeks]
days of being hospitalized
- Physical activity [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Measured through an activity tracker (hours)
- Diastolic blood pressure [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Diastolic blood pressure (mmHg) measured at rest
- Systolic blood pressure [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Systolic blood pressure (mmHg) measured at rest
- Endothelial function [Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks]
Measured through the passive leg movement (PLM) technique through ultrasound measurements (blood flow in mL/min)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of resectable pancreatic cancer
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Diagnosis of resectable biliary tract cancer (includes cholangiocarcinoma and ampullary cancer)
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ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2
Exclusion Criteria:
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Serious active infection
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Uncontrolled severe pain
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Severe neurologic or cardiac impairment according ACSM criteria
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Uncontrolled severe respiratory insufficiency as determined by the treating clinician
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Any other contraindications for exercise as determined by the treating physician
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Poor Swedish comprehension
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oslo University Hospital | Oslo | Norway | ||
| 2 | Karolinska University Hopsital | Stockholm | Sweden |
Sponsors and Collaborators
- Karolinska Institutet
- Karolinska University Hospital
- Norwegian School of Sport Sciences
- Oslo University Hospital
Investigators
- Principal Investigator: Sara Mijwel, PhD, Karolinska Institutet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PREV-Ex