Could supported weight loss reduce womb cancer surgery complications?
Research type
Research Study
Full title
Pre-operative intentional weight loss to support post-operative recovery in patients with overweight and endometrial cancer: the ENDO-CARE feasibility randomised controlled trial
IRAS ID
324534
Contact name
Dimitrios Koutoukidis
Contact email
Sponsor organisation
Research Governance, Ethics and Assurance
ISRCTN Number
ISRCTN13577800
Duration of Study in the UK
4 years, 5 months, 29 days
Research summary
In the UK 10,000 women each year are diagnosed with womb cancer. Surgery to remove the cancer is the best treatment. However, it has a risk of complications, which is higher for people with overweight/obesity. 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 womb 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 patients with womb 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.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0223
Date of REC Opinion
3 Aug 2023
REC opinion
Further Information Favourable Opinion