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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
CARE trial team
CARE trial team
+441865617767
care@nds.ox.ac.uk
Dr
Dimitrios
Koutoukidis
+44(0)1865617767
dimitrios.koutoukidis@phc.ox.ac.uk
Dr
Dimitrios
Koutoukidis
+44(0)1865617767
dimitrios.koutoukidis@phc.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Colorectal cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
In the UK, 42,000 people each year are diagnosed with bowel cancer. It is the fourth most common cancer. Surgery to remove the cancer is the best treatment. However, it has a risk of complications, which is doubled for people who are overweight/obese. Patients experiencing complications recover more slowly, stay in the hospital longer and need more care. This isn’t good for patients or the NHS. Physical fitness and well-controlled blood sugar are linked with fewer complications from surgery. For people who are overweight, weight loss improves both of these factors so that it may reduce complications. One reliable way to lose a meaningful amount of weight in the short period before surgery (3-4 weeks) is through a low-calorie diet programme: eating only special nutritious soups and shakes (880 calories/day) that have all the necessary vitamins. With weekly support from a dietitian, most people succeed. Typically, people lose 5% of their weight within 20 days. The NHS uses a version of this programme to treat type 2 diabetes. In small-scale studies, patients with cancer who are overweight have been willing and able to take part in less intensive weight management programmes before surgery but lose little weight. However, the period before bowel cancer surgery is associated with feelings of uncertainty and anxiety, so it is unclear if patients can follow a more intensive programme.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37525408/ (added 21/08/2023)2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38969979/ Participants' perspectives (added 08/07/2024)
You can take part if:
You may not be able to take part if:
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 visit2. <20 days from the screening visit until surgery3. Having allergy to soy4. Documented stage 4-5 kidney disease5. Documented severe heart failure (defined as New York Heart Association grade 3 or 4)6. Previous bariatric surgery7. Type 1 diabetes8. Currently on warfarin9. Currently on insulin with a previous episode of diabetic ketoacidosis10. Radiological suspicion of imminent intestinal obstruction or endoscopic evidence of an impassable tumour11. Pregnancy, breastfeeding, or planning pregnancy during the course of the trial12. 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 trial13. 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 visit2. <20 days from the screening visit until surgery3. Follows an exclusively vegan diet, has lactose intolerance or has an allergy to soy4. Documented stage 4-5 kidney disease5. Documented severe heart failure (defined as New York Heart Association grade 3 or 4)6. Previous bariatric surgery7. Type 1 diabetes8. Currently on warfarin9. Pregnancy, breastfeeding, or planning pregnancy during the course of the trial10. 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.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Dimitrios
Koutoukidis
+44(0)1865617767
dimitrios.koutoukidis@phc.ox.ac.uk
Dr
Dimitrios
Koutoukidis
+44(0)1865617767
dimitrios.koutoukidis@phc.ox.ac.uk
Mr
CARE trial team
CARE trial team
+441865617767
care@nds.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Oxford and funded by National Institute for Health and Care Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 54218
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
