Clinical trial NCT04880772: Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery
Official title: A Single-centre Two-armed Randomised Controlled Trial Comparing Standard Care Alone Versus Exercise and Nutrition Prehabilitation in Elective Patients Undergoing Resectional HPB and Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Colon
Cancer of Rectum
Liver Metastases
Keywords: prehabilitation
surgery
cardiopulmonary exercise testing
cytokines
Lead sponsor: East Lancashire Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Lancaster University
First posted: 2021-05-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomisation to standard care or prehabilitation
Primary purpose: TREATMENT

Brief summary: To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery

Detailed description: Preliminary qualitative and quantitative studies suggest that there are benefits (reduced length of stay, improved cardiorespiratory function, reduced postoperative complications and improved quality of life) when prehabilitation is used with the context of cancer care. In 2017 Macmillian Cancer Support developed a strategic 'Evidence and Insight' review on prehabilitation. The outcome of this was to incorporate prehabilitation into routine cancer care and to develop principles and guidance for prehabilitation. This study aims to support this vision and answer some of the questions on the patients who are most likely to benefit from prehabilitation and to quantify some of these benefits by investigating the molecular processes that influence clinical changes

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.

Eligibility criteria: Inclusion Criteria:

* Aged 18-85
* 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:

Exclusion

* 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)

Primary outcomes:
measure: Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min
timeFrame: change in baseline AT & VO2 peak at 4 weeks
measure: Inflammatory cytokines
timeFrame: change in baseline cytokines at 4 weeks
Secondary outcomes:
measure: Clavien-Dindo complication rates
timeFrame: Up to 30 days from the day of operation
measure: Length of hospital stay measured in days
timeFrame: 30 & 90-day mortality
measure: Quality of life measures (Illness Perception Questionnaire)
timeFrame: baseline and within 24 weeks after surgery
measure: Hand Grip Strength measured in kg
timeFrame: baseline, immediately after the intervention, within 24 weeks after surgery
measure: Quality of life measure (Mental Adjustment to Cancer Scale)
timeFrame: baseline and within 24 weeks after surgery
Other outcomes:
Locations:
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
Study officials:
affiliation: Senior Clinical Research Fellow
name: Joel Lambert
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster University
name: Chris Gaffney
role: STUDY_DIRECTOR
References:
citation: 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.