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| Name | Class |
|---|---|
| Lancaster University | OTHER |
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To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | Standard Care: Surgery school as per ELHT pre-operative guidelines (includes generic pre-operative information, advice and optimisation e.g correction of anaemia) | |
| Prehabilitation | Experimental | Surgery School plus Moderate intensity exercise & Forceval (multivitamin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Other | exercise & multivitamin (nutritional/dietary advice) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min | Cardiopulmonary exercise Test (CPET) variables | change in baseline AT & VO2 peak at 4 weeks |
| Inflammatory cytokines | IL6 IL10 in muscle and blood measured in pg/ml | change in baseline cytokines at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clavien-Dindo complication rates | Grades I-IV | Up to 30 days from the day of operation |
| Length of hospital stay measured in days | Defined as duration of stay from date of operation to discharge |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Joel Lambert | Senior Clinical Research Fellow | Principal Investigator |
| Chris Gaffney | Lancaster University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Blackburn Hospital | Blackburn | BB@ 3HH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33201129 | Background | 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. |
| Label | URL |
|---|---|
| study website | View source |
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Anonymised CPET data to be shared with other researchers. Anonymised tissue and blood samples to be shared with other researchers for analysis
18 months
Full anonymisation
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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1:1 randomisation to standard care or prehabilitation
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CPET clinician/physiologist will be blinded
| 30 & 90-day mortality |
| Quality of life measures (Illness Perception Questionnaire) | 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. | baseline and within 24 weeks after surgery |
| Hand Grip Strength measured in kg | Measured by digital dynamometer | baseline, immediately after the intervention, within 24 weeks after surgery |
| Quality of life measure (Mental Adjustment to Cancer Scale) | 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. | baseline and within 24 weeks after surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |