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

Primary Purpose

Pancreatic Cancer, Biliary Tract Cancer, Liver Cancer

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital
  • Karolinska University HopsitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Usual care

Arm 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.

The control group will in addition to standard care receive protein supplementation to ensure adequate protein intake.

Outcomes

Primary Outcome Measures

Skeletal muscle thickness
Skeletal muscle thickness (mm) measured through ultrasound
Skeletal muscle cross sectional area
Skeletal muscle cross sectional area (um2) measured through ultrasound

Secondary Outcome Measures

Skeletal muscle morphology
Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies
Skeletal muscle protein levels
Skeletal muscle protein levels (au) measured through western blot in skeletal muscle biopsies
Skeletal muscle metabolism
Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies
Body lean mass
Lean mass (kg) measured through bioimpedance and CT scan
Body fat mass
Fat mass (kg) measured through bioimpedance and CT scan
Handgrip strength
Maximal handgrip strength (kg) measured through hand dynamometry
Lower limb muscle strength
Maximal led strength (kg) measured through isometric force measurements
Health-related quality of life
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
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
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
Subjective Global Assessment Form scores (score ranging between 7 (normal) and 35 (severely malnourished)
Participants' experience of the exercise program
Focus group interviews
Treatment related complications
days to recover after surgery
Treatment related complications
days to recover after surgery
Treatment related complications
days to recover after surgery
Hospitalization
days of being hospitalized
Hospitalization
days of being hospitalized
Hospitalization
days of being hospitalized
Physical activity
Measured through an activity tracker (hours)
Diastolic blood pressure
Diastolic blood pressure (mmHg) measured at rest
Systolic blood pressure
Systolic blood pressure (mmHg) measured at rest
Endothelial function
Measured through the passive leg movement (PLM) technique through ultrasound measurements (blood flow in mL/min)

Full Information

First Posted
August 16, 2021
Last Updated
October 20, 2023
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Norwegian School of Sport Sciences, Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05044065
Brief Title
Metabolic Stress-induced Exercise to Prevent Loss of Muscle Mass in Patients With Pancreatic and Biliary Tract Cancer
Acronym
PREV-Ex
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Norwegian School of Sport Sciences, Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Biliary Tract Cancer, Liver Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The control group will in addition to standard care receive protein supplementation to ensure adequate protein intake.
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skeletal muscle thickness
Description
Skeletal muscle thickness (mm) measured through ultrasound
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Skeletal muscle cross sectional area
Description
Skeletal muscle cross sectional area (um2) measured through ultrasound
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Skeletal muscle morphology
Description
Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies
Time Frame
Change from baseline to: 2 weeks, 8 weeks
Title
Skeletal muscle protein levels
Description
Skeletal muscle protein levels (au) measured through western blot in skeletal muscle biopsies
Time Frame
Change from baseline to: 2 weeks, 8 weeks
Title
Skeletal muscle metabolism
Description
Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies
Time Frame
Change from baseline to: 2 weeks, 8 weeks
Title
Body lean mass
Description
Lean mass (kg) measured through bioimpedance and CT scan
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Body fat mass
Description
Fat mass (kg) measured through bioimpedance and CT scan
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Handgrip strength
Description
Maximal handgrip strength (kg) measured through hand dynamometry
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Lower limb muscle strength
Description
Maximal led strength (kg) measured through isometric force measurements
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Health-related quality of life
Description
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 to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Physical performance
Description
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 to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Cancer-related fatigue
Description
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 to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Nutritional status
Description
Subjective Global Assessment Form scores (score ranging between 7 (normal) and 35 (severely malnourished)
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Participants' experience of the exercise program
Description
Focus group interviews
Time Frame
8 weeks
Title
Treatment related complications
Description
days to recover after surgery
Time Frame
4 weeks
Title
Treatment related complications
Description
days to recover after surgery
Time Frame
8 weeks
Title
Treatment related complications
Description
days to recover after surgery
Time Frame
16 weeks
Title
Hospitalization
Description
days of being hospitalized
Time Frame
4 weeks
Title
Hospitalization
Description
days of being hospitalized
Time Frame
8 weeks
Title
Hospitalization
Description
days of being hospitalized
Time Frame
16 weeks
Title
Physical activity
Description
Measured through an activity tracker (hours)
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure (mmHg) measured at rest
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Systolic blood pressure
Description
Systolic blood pressure (mmHg) measured at rest
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks
Title
Endothelial function
Description
Measured through the passive leg movement (PLM) technique through ultrasound measurements (blood flow in mL/min)
Time Frame
Change from baseline to: 2 weeks, 4 weeks, 8 weeks, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Mijwel, PhD
Phone
+46761625352
Email
sara.mijwel@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Mijwel, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Truls Raastad, PhD
Facility Name
Karolinska University Hopsital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Mijwel, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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