Brief Title
Metabolic Stress-induced Exercise to Prevent Loss of Muscle Mass in Patients With Pancreatic and Biliary Tract Cancer
Official Title
Metabolic Stress-induced Exercise in the Perioperative Setting to Prevent the Loss of Muscle Mass in Patients With Pancreatic and Biliary Tract Cancer - the PREV-Ex Randomized Controlled Trial
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.
Study Type
Interventional
Primary Outcome
Skeletal muscle thickness
Secondary Outcome
Skeletal muscle morphology
Condition
Pancreatic Cancer
Intervention
Physical exercise
Study Arms / Comparison Groups
Exercise group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
52
Start Date
September 14, 2021
Completion Date
December 31, 2024
Primary Completion Date
December 31, 2023
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of resectable pancreatic cancer
- Diagnosis of resectable biliary tract cancer (includes cholangiocarcinoma and
ampullary 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
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sara Mijwel, PhD, +46761625352, [email protected]
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT05044065
Organization ID
PREV-Ex
Responsible Party
Principal Investigator
Study Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
Study Sponsor
Sara Mijwel, PhD, Principal Investigator, Karolinska Institutet
Verification Date
September 2021