Pre-operative intentional weight loss to support post-operative recovery in patients with overweight and colorectal cancer: the CARE feasibility randomised controlled trial

Study ID: 54218
Short Title: Could supported weight loss reduce bowel cancer surgery complications?
Trust Name: DCHFT,UHD
Recruitment Site: Dorset County Hospital,Poole Hospital
Disease Area: Colorectal cancer
Phase: N/A
Expected End Date: 30/06/2024
Postcode: DT1 2JY
BH15 2JB
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

• Participant is willing and able to give informed consent for participation in the study. • Able to communicate in English or has a relative/friend/carer acting as interpreter. • Aged 18 years or above. • BMI > = 28 kg/m2 (or BMI > = 25 kg/m2 for people of Black, Asian, or minority ethnic origin). • Listed for curative elective colorectal resection for cancer. • If neoadjuvant treatment is indicated, it must have been completed. • Performance status 0-2.

• > = 10% self-reported weight loss in the 6 months before the screening visit • < 20 days from the screening visit until surgery. • Follows an exclusively vegan diet, having lactose intolerance, or having allergy to soy. • Documented stage 4-5 kidney disease. • Documented severe heart failure (defined as New York Heart Association grade 3 or 4). • Previous bariatric surgery. • Type 1 diabetes. • Currently on warfarin. • Pregnancy, breastfeeding, or planning pregnancy during the course of the trial. • 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. • Currently taking part in other interventional clinical trials unless agreed in advance by all trial teams (participation in observational studies is allowed).

In the UK 42,000 people each year are diagnosed with bowel cancer. Surgery to remove the cancer is the best treatment. However, it has a risk of complications, which is doubled for people with overweight/besity. Patients experiencing complications recover more slowly, stay in 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 with overweight, weight loss improves both of these factors, so 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. 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. To start to find out if this treatment is in the best interests of patients physical and mental health, we will recruit 72 patients with overweight awaiting bowel cancer surgery. Half will be randomly allocated to continue with their usual care and half will be offered the weight loss programme. We will see whether enough patients are willing to take part, lose weight, and return for follow-up visits. We will monitor complications for 30 days after surgery and any reduction in muscle mass as a result of the weight loss. We will interview patients about their experience. This information will tell us if a full trial is worthwhile to test whether this programme can reduce complications from surgery, improve outcomes for people with bowel cancer, and if the financial costs are likely to be worth the benefits. It will also help us refine the treatment plans according to patient feedback.

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