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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
CPET clinician/physiologist will be blinded
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
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)
Prehabilitation
Surgery School plus Moderate intensity exercise & Forceval (multivitamin)
Intervention: Prehabilitation (Other)
Outcomes
Primary Outcomes
Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min
Time Frame: change in baseline AT & VO2 peak at 4 weeks
Cardiopulmonary exercise Test (CPET) variables
Inflammatory cytokines
Time Frame: change in baseline cytokines at 4 weeks
IL6 IL10 in muscle and blood measured in pg/ml
Secondary Outcomes
- Clavien-Dindo complication rates(Up to 30 days from the day of operation)
- Hand Grip Strength measured in kg(baseline, immediately after the intervention, within 24 weeks after surgery)
- Length of hospital stay measured in days(30 & 90-day mortality)
- Quality of life measures (Illness Perception Questionnaire)(baseline and within 24 weeks after surgery)
- Quality of life measure (Mental Adjustment to Cancer Scale)(baseline and within 24 weeks after surgery)
Investigators
Joel Lambert
Clinical Research Fellow
East Lancashire Hospitals NHS Trust