Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery
NCT ID: NCT04880772
Last Updated: 2023-09-07
Study Results
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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COMPLETED
NA
42 participants
INTERVENTIONAL
2021-07-15
2023-07-13
Brief Summary
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Detailed Description
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This study primarily seeks to assess the cardiovascular and biological impact of prehabilitation (exercise, nutrition) on patients undergoing hepatobiliary and colorectal cancer surgery. The investigators aim to assess whether there is an improvement in various cardiopulmonary exercise testing (CPET) variables such as maximum oxygen consumption and anaerobic threshold. The investigators also aim to study the inflammatory cytokines associated with cancer and how these markers respond to exercise. These inflammatory markers are thought to play a role in influencing some clinical outcomes such as wound infection and recovery.
The study will also assess secondary outcomes including hospital stay, post operative complications and quality of life. The investigators aim to better understand the biological relationship between anti-inflammatory cytokine levels and the previously mentioned outcomes by measuring and analysing these mediators and performing selected muscle biopsies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard care
Standard Care: Surgery school as per ELHT pre-operative guidelines (includes generic pre-operative information, advice and optimisation e.g correction of anaemia)
No interventions assigned to this group
Prehabilitation
Surgery School plus Moderate intensity exercise \& Forceval (multivitamin)
Prehabilitation
exercise \& multivitamin (nutritional/dietary advice)
Interventions
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Prehabilitation
exercise \& multivitamin (nutritional/dietary advice)
Eligibility Criteria
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Inclusion Criteria
* Sex: male/female
* Radiological/tissue cancer diagnosis
* Curative cancer of the colon, rectum, colorectal liver metastases (CRLM) of 2 or more segments
* elective surgery (planned a minimum of 3 weeks from the date of first clinic meeting)
* Access to digital technology(mobile phone, tablet or laptop, home computer) to participate in supervised home exercise
Exclusion Criteria
* Palliative disease
* Haematological malignancy
* Pregnancy
* Emergency surgery
* Physically unable to undergo CPET
* Part of any other trial with similar interventions unless previously agreed on with all CIs
* synchronous disease (operation on HPB \& colorectal cancers at the same operation)
* No access to digital technology(smart phone, tablet, laptop or home computer)
18 Years
85 Years
ALL
No
Sponsors
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Lancaster University
OTHER
East Lancashire Hospitals NHS Trust
OTHER
Responsible Party
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Joel Lambert
Clinical Research Fellow
Principal Investigators
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Joel Lambert
Role: PRINCIPAL_INVESTIGATOR
Senior Clinical Research Fellow
Chris Gaffney
Role: STUDY_DIRECTOR
Lancaster University
Locations
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Royal Blackburn Hospital
Blackburn, , United Kingdom
Countries
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References
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Lambert JE, Hayes LD, Keegan TJ, Subar DA, Gaffney CJ. The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Ann Surg. 2021 Jul 1;274(1):70-77. doi: 10.1097/SLA.0000000000004527.
Related Links
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study website
Other Identifiers
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290723
Identifier Type: -
Identifier Source: org_study_id
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