Prehabilitation in patients with colorectal cancer scheduled for surgery with curative intent Cancer
Conditions
Interventions
Patients attend a testing session to assess their physical function and measure muscle mass and structure using whole-body x-ray and ultrasound. Patients will be asked to complete simple questionnaire
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years at the time of discussion at the multidisciplinary team 2. No maximum age range so long as the participant is deemed fit for surgery by the clinical team 3. MDT outcome of a tissue-proven, or radiologically and clinically suspected colorectal neoplasia or dysplasia with the intention to treat with curative surgery 4. Due to undergo elective operative resection (by any route) with curative intent 5. Ability to and willingness to participate in exercise regimes and assessments 6. Able to travel to the Royal Derby Hospital for the duration of the study to facilitate exercise sessions 7. Availability for the study period to attend a minimum of eight exercise sessions and three assessment sessions
Exclusion criteria
Exclusion criteria: 1. Age <18 years at the time of discussion at the multidisciplinary team 2. No maximum age range so long as the participant is deemed fit for surgery by the clinical team 3. MDT outcome of a tissue-proven, or radiologically and clinically suspected colorectal neoplasia or dysplasia with the intention to treat with curative surgery 4. Due to undergo elective operative resection (by any route) with curative intent 5. Ability to and willingness to participate in exercise regimes and assessments 6. Able to travel to the Royal Derby Hospital for the duration of the study to facilitate exercise sessions 7. Availability for the study period to attend a minimum of eight exercise sessions and three assessment sessions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite primary endpoint of change in anaerobic threshold determined via cardiopulmonary exercise testing (CPET) (Hedges g effect size: 1.32) and whole-body muscle mass measured by dual-energy X-ray absorptiometry (DXA) (Hedges g effect size: 1.1) measured at baseline, pre-op (approx. 4 weeks after baseline) and 6 weeks post-op (approx. 10 weeks after baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| All outcome measures except those detailed otherwise will be measured at baseline, pre-op (approx. 4 weeks after baseline) and 6 weeks post-op (approx. 10 weeks after baseline): 1. Muscle protein synthesis determined via laboratory analysis of vastus lateralis muscle and saliva collection in conjunction with consumption of D2O 2. Muscle protein breakdown determined via blood sample analysis and 3-methylhistidine tracer consumption 3. Whole-body contractile mass determined via urine sample analysis and D3-creatine tracer consumption 4. VO2 peak determined via CPET 5. VL muscle architecture determined via muscle ultrasound 6. Neuromuscular function determined via electromyography 7. Mitochondrial respiration determined via Oroboros analysis of vastus lateralis biopsies 8. Anabolic cell signalling determined via Western blotting analysis of vastus lateralis biopsies 9. Clinical outcomes determined via hospital data at the end of the study (approx. 10 weeks), or earlier if information becomes available 10. Dietary intake determined by analysis of a 4-day diet diary undertaken at four timepoints: prior to the first assessment (baseline assessment), during the intervention period (week 0-4), immediately post-operation (approx. week 4-5), and 3 weeks after the operation (approx. week 7-8) 11. Functionality (including physical activity) determined via a 6-minute walk test, handgrip strength, a short performance physical battery test (measuring balance, chair-rise ability and natural gait speed), a vertical jump test (using a G-Walk [Gait and Motion Technology Ltd, Bury St Edmunds] device), exercise assessments, Duke Activity Status Questionnaire, and leg-extensions measured via dynamometery 12. Habitual activity determined using a wearable device (ActivPAL™ monitor) at four timepoints: prior to the first assessment (baseline assessment), during the intervention period (week 0-4), immediately post-operation (approx. week 4-5), and 3 weeks after the operation (approx. week 7- | — |
Countries
England, United Kingdom
Contacts
Public ContactWayne Fradley
Outcome results
None listed