Metabolic Stress-induced Exercise to Prevent Loss of Muscle Mass in Patients With Pancreatic and Biliary Tract Cancer

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Usual care
    • The control group will in addition to standard care receive protein supplementation to ensure adequate protein intake.

Clinical Trial Outcome Measures

Primary Measures

  • Skeletal muscle thickness
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Skeletal muscle thickness (mm) measured through ultrasound
  • Skeletal muscle cross sectional area
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Skeletal muscle cross sectional area (um2) measured through ultrasound

Secondary Measures

  • Skeletal muscle morphology
    • Time Frame: Change from baseline to: 2 weeks, 8 weeks
    • Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies
  • Skeletal muscle protein levels
    • Time Frame: Change from baseline to: 2 weeks, 8 weeks
    • Skeletal muscle protein levels (au) measured through western blot in skeletal muscle biopsies
  • Skeletal muscle metabolism
    • Time Frame: Change from baseline to: 2 weeks, 8 weeks
    • Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies
  • Body lean mass
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Lean mass (kg) measured through bioimpedance and CT scan
  • Body fat mass
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Fat mass (kg) measured through bioimpedance and CT scan
  • Handgrip strength
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Maximal handgrip strength (kg) measured through hand dynamometry
  • Lower limb muscle strength
    • Time Frame: 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
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score
  • Physical performance
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Short Physical Performance Battery (SPPB score points) measured through handgrip strength test, leg strength test, endurance test
  • Cancer-related fatigue
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • EORTC QLQ-FA12 scores
  • Nutritional status
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Subjective Global Assessment Form scores
  • Participants’ experience of the exercise program
    • Time Frame: 8 weeks
    • Focus group interviews
  • Treatment related complications
    • Time Frame: 4 weeks
    • days to recover after surgery
  • Treatment related complications
    • Time Frame: 8 weeks
    • days to recover after surgery
  • Treatment related complications
    • Time Frame: 16 weeks
    • days to recover after surgery
  • Hospitalization
    • Time Frame: 4 weeks
    • days of being hospitalized
  • Hospitalization
    • Time Frame: 8 weeks
    • days of being hospitalized
  • Hospitalization
    • Time Frame: 16 weeks
    • days of being hospitalized
  • Physical activity
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Measured through an activity tracker (hours)
  • Diastolic blood pressure
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Diastolic blood pressure (mmHg) measured at rest
  • Systolic blood pressure
    • Time Frame: Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
    • Systolic blood pressure (mmHg) measured at rest
  • Endothelial function
    • Time Frame: 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)

Participating in This Clinical Trial

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 Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Collaborator
    • Karolinska University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sara Mijwel, Principal Investigator – Karolinska Institutet
  • Overall Official(s)
    • Sara Mijwel, PhD, Principal Investigator, Karolinska Institutet
  • Overall Contact(s)
    • Sara Mijwel, PhD, +46761625352, sara.mijwel@ki.se

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