Colorectal cancer Cancer
Conditions
Interventions
This is a randomised controlled trial to assess a low-energy total diet replacement programme with behavioural support which will also look at the feasibility of progression to a definitive trial that
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Able to communicate in English or has a relative/friend/carer acting as interpreter 3. Aged 18 years or above 4. BMI =28 kg/m2 (or BMI =25 kg/m2 for people of Black, Asian, or minority ethnic origin) 5. Listed for curative elective colorectal resection for cancer 6. If neoadjuvant treatment is indicated, it must have been completed 7. Performance status 0-2
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 20/11/2023: The participant may not enter the study if ANY of the following apply: 1. =10% self-reported weight loss in the 6 months before the screening visit 2. <20 days from the screening visit until surgery 3. Having allergy to soy 4. Documented stage 4-5 kidney disease 5. Documented severe heart failure (defined as New York Heart Association grade 3 or 4) 6. Previous bariatric surgery 7. Type 1 diabetes 8. Currently on warfarin 9. Currently on insulin with a previous episode of diabetic ketoacidosis 10. Radiological suspicion of imminent intestinal obstruction or endoscopic evidence of an impassable tumour 11. Pregnancy, breastfeeding, or planning pregnancy during the course of the trial 12. Any other significant disease or disorder which, in the opinion of the Investigator or healthcare professional, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 13. Currently taking part in other interventional clinical trials unless agreed in advance by all trial teams (participation in observational studies is allowed) A list of trials that co-enrolment has been agreed upon by all trial teams and a list of trials that co-enrolment has been agreed not to be allowed will be regularly updated and provided to trial sites. _____ Previous exclusion criteria: The participant may not enter the study if ANY of the following apply: 1. =10% self-reported weight loss in the 6 months before the screening visit 2. <20 days from the screening visit until surgery 3. Follows an exclusively vegan diet, has lactose intolerance or has an allergy to soy 4. Documented stage 4-5 kidney disease 5. Documented severe heart failure (defined as New York Heart Association grade 3 or 4) 6. Previous bariatric surgery 7. Type 1 diabetes 8. Currently on warfarin 9. Pregnancy, breastfeeding, or planning pregnancy during the course of the trial 10. Any other significant disease or disorder which, in the opinion of the Investigator or healthcare professional, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. 11. Currently taking part in other interventional clinical trials unless agreed in advance by all trial teams (participation in observational studies is allowed). A list of trials that co-enrolment has been agreed upon by all trial teams and a list of trials that co-enrolment has been agreed not to be allowed will be regularly updated and provided to trial sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility to progression to a definitive randomised controlled trial is the primary objective. This will be judged based on 5 outcome measures: 1. Recruitment rate measured using the number of sites open, the total n participants recruited, and the number of participants recruited per site as documented in the study notes per month 2. Engagement rate measured using the mean proportion of phone calls answered per participant documented in the study notes at one timepoint 3. Adherence rate measured using the proportion of intervention participants with =5% weight loss documented in the study notes from baseline to the day of surgery 4. Retention rate measured using the proportion of participants documented in the study notes as attending their final follow-up (30 days post-operatively) 5. Safety profile measured using related adverse events and expected related and unexpected related serious adverse events documented in the study notes throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity will be assessed from patient records at discharge and 30 days postoperatively using the Clavien-Dindo classification as follows: 1. Any morbidity 2. Morbidity by grade (II, IIIa, IIIb, IVa, IVb) Oncological outcomes will be assessed from patient records at discharge and 30 days postoperatively using: 3. Survival (grade V) 4. Resection margins 5. Recurrence 6. New primary/secondary cancer Operative outcomes will be assessed from patient records at discharge and 30 days postoperatively using: 7. Intraoperative blood loss 8. Operative time 9. Conversion to open surgery 10. Surgical site infection 11. Stoma rates and complications 12. Radiologically-defined anastomotic leaks 13. Time in the intensive care unit and high-dependency unit 14. Re-operation rates 15. Re-admission rates Hospital stay will be assessed from patient records at discharge and 30 days postoperatively using: 16. Length of hospital stay (fitness to discharge) 17. Days alive and out of hospital Anthropometry will be assessed by measuring in-person at baseline, on admission, and 30 days postoperatively using: 18. Weight 19. Fat-free mass Fitness will be assessed by measuring in-person at baseline and 30 days postoperatively using: 20. Time for sit-to-stand test Health-related quality of life will be self-reported at baseline, 4 days preoperatively, and 30 days postoperatively using: 21. EQ-5D-5L 22. HADS Health-related quality of life will be self-reported at 30 days postoperatively using: 23. EORTC-QLQ-CR29 Costs and resource use will be assessed from trial records and by self-report at baseline and 30 days postoperatively using: 24. Intervention costs 25. Healthcare resource use questionnaire 26. QALYs 27. Adverse events will be self-reported throughout the study | — |
Countries
England, United Kingdom
Contacts
Public ContactCARE trial team CARE trial team
Outcome results
None listed