Blood Flow Restriction Exercise in Patients With Pancreatic, Biliary Tract, and Liver Cancer (PREV-Ex)

Pancreatic Cancer Clinical Trial

— PREV-Ex  

Official title:

Blood Flow Restriction Exercise in the Perioperative Setting to Prevent the Loss of Muscle Mass in Patients With Pancreatic, Biliary Tract, and Liver Cancer - the PREV-Ex Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044065
• Other study ID #: PREV-Ex
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Karolinska Institutet
• Contact: Sara Mijwel, PhD
• Phone: +46761625352
• Email: sara.mijwel[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Liver Cancer
• Liver Neoplasms
• Pancreatic Cancer

Intervention

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 (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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo
Sweden	Karolinska University Hopsital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital, Norwegian School of Sport Sciences, Oslo University Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle thickness	Skeletal muscle thickness (mm) measured through ultrasound	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Primary	Skeletal muscle cross sectional area	Skeletal muscle cross sectional area (um2) measured through ultrasound	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Secondary	Skeletal muscle morphology	Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies	Change from baseline (T0) to: 10-13 weeks (T3).
Secondary	Skeletal muscle protein levels	Skeletal muscle protein levels (au) measured through western blot in skeletal muscle biopsies	Change from baseline (T0) to: 10-13 weeks (T3).
Secondary	Skeletal muscle metabolism	Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies	Change from baseline (T0) to: 10-13 weeks (T3).
Secondary	Body lean mass	Lean mass (kg) measured through bioimpedance and CT scan	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Secondary	Body fat mass	Fat mass (kg) measured through bioimpedance and CT scan	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Secondary	Handgrip strength	Maximal handgrip strength (kg) measured through hand dynamometry	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Secondary	Lower limb muscle strength	Maximal led strength (kg) measured through isometric force measurements	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Secondary	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)	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
Secondary	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	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Secondary	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)	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
Secondary	Nutritional status	Subjective Global Assessment Form scores (score ranging between 7 (normal) and 35 (severely malnourished)	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
Secondary	Participants' experience of the exercise program	Focus group and individual interviews	3 months
Secondary	Treatment related complications	days to recover after surgery will be assessed retrospectively through the patients' medical records.	4-7 weeks (T2)
Secondary	Hospitalization	days of being hospitalized will be assessed retrospectively through the patients' medical records.	5-6 months (T4)
Secondary	Physical activity	Measured through an activity tracker (hours)	Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).
Secondary	Inflammatory markers	Inflammation (au) will be assessed from blood serum and plasma.	Change from baseline (T0) to: 10-13 weeks (T3)
Secondary	Prognostic markers	Prognostic markers (au) will be assessed from blood serum and plasma.	Change from baseline (T0) to: 10-13 weeks (T3)