Royal Blackburn Hospital
Blackburn, BB@ 3HH, United Kingdom
NCT Number: NCT04880772
To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Blackburn, BB@ 3HH, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion
exercise & multivitamin (nutritional/dietary advice)
Time frame: change in baseline AT & VO2 peak at 4 weeks
Cardiopulmonary exercise Test (CPET) variables
Time frame: change in baseline cytokines at 4 weeks
IL6 IL10 in muscle and blood measured in pg/ml
Time frame: Up to 30 days from the day of operation
Grades I-IV
Time frame: 30 & 90-day mortality
Defined as duration of stay from date of operation to discharge
Time frame: baseline and within 24 weeks after surgery
This questionnaire assesses perceptions on each of the five dimensions(Identity, Cause, Timeline, Consequences, Cure-Control) by asking patients for their own beliefs about their condition.
High scores on the identity, consequences, timeline acute/ chronic and cyclical subscales represent strongly held beliefs about the number of symptoms attributed, the negative consequences, and the chronicity and cyclical nature of the illness.
High scores on the identity and cure-control and coherence subscales represent positive beliefs about controllability and a personal understanding of the illness.
Time frame: baseline, immediately after the intervention, within 24 weeks after surgery
Measured by digital dynamometer
Time frame: baseline and within 24 weeks after surgery
Assessment of participants mental adjustment to a cancer diagnosis. Designed to measure Fighting Spirit (FS), Anxious Preoccupation (AP), Helpless-hopelessness (HH) and Fatalism. This is a 40-item measure of specific psychological (Coping) responses that cancer patients may display in the process of adjusting to the diagnosis and treatment of their disease.
A higher score represents higher endorsement of the adjustment response.
East Lancashire Hospitals NHS Trust
Other
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
Acronym: SPECS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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