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

Karolinska Institute

Status: Completed

Conditions: Biliary Tract Cancer; Liver Cancer; Pancreatic Cancer

Treatments: Other: Physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05044065

PREV-Ex

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Exercise group

Experimental 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 (blood flow restriction exercise), and protein supplementation to ensure adequate protein intake.

Treatment:

Other: Physical exercise

Usual care

No Intervention group

Description:

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