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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cancer Biliary Tract Cancer Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Physical exercise

Intervention Type OTHER

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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No