CompletedInterventional

Could supported weight loss reduce bowel cancer surgery complications?

Around 42,000 people in the UK are diagnosed with bowel cancer each year, and surgery is often the main treatment. However, carrying extra weight can double the chance of surgical complications, which can mean a slower recovery and a longer stay in hospital. The CARE study is exploring whether a safe, rapid weight-loss plan before surgery can help. Participants are randomly put into one of two groups. One group continues with standard NHS care. The other group follows a meal-replacement programme of nutritious soups and shakes (around 880 calories a day) with regular dietitian support for three to four weeks leading up to their operation. Researchers want to see if patients find this programme manageable during a stressful time, and whether it helps reduce complications after surgery. This small trial will show if a larger study is practical.

At a glance

Status

Completed

Sponsor

University of Oxford

Enrolment target

Start

23 Mar 2023

Estimated completion

13 Aug 2024

Colorectal cancer

What is this study about?

Bowel cancer is the fourth most common cancer in the UK. For many people, having an operation to remove the cancer offers the best chance of a cure. However, major surgery carries risks. People who are overweight face roughly double the risk of complications, such as infections or breathing issues, which can lead to longer hospital stays and a tougher recovery.

Research shows that improving fitness and blood sugar control can lower these risks. One proven way to improve both quickly is through safe, short-term weight loss. In this study, called the CARE trial, researchers want to see if a low-calorie diet programme before surgery helps patients recover more smoothly.

The programme replaces ordinary meals with specially formulated, vitamin-rich soups and shakes providing about 880 calories a day. In similar NHS programmes for type 2 diabetes, people usually lose around 5% of their body weight in three weeks with weekly support from a dietitian. However, waiting for cancer surgery is an anxious time, so researchers need to find out whether patients feel able and willing to follow this kind of diet.

In this study, half the participants will follow the soup and shake plan with professional guidance, while the other half receive standard care. Researchers will track how patients get on, check their recovery for 30 days after surgery, and listen to their personal feedback. This will show whether a larger, nationwide trial should be run in the future.

Key takeaways

Tests whether a rapid weight-loss diet before bowel cancer surgery lowers recovery complications.
Half of the participants follow a soup and shake diet for 3-4 weeks; the other half receive usual care.
Participants on the diet receive weekly support from a trained dietitian.
Joining the study will not delay your planned surgery date.
Participation is entirely voluntary and you can leave the study at any time.

Who may be eligible?

You may be able to take part if you are aged 18 or older and are scheduled to have planned surgery to remove bowel cancer. You also need to have a body mass index (BMI) of 28 or higher, or 25 or higher if you are from a Black, Asian, or minority ethnic background. Any chemotherapy or radiotherapy planned before your surgery must already be finished, and your operation must be at least 20 days away.

You will not be able to join if you have already lost 10% or more of your body weight without trying over the past six months, or if you have had weight-loss surgery in the past. People with type 1 diabetes, severe heart or kidney disease, a soy allergy, or those taking warfarin are also unable to take part. The study is not suitable for anyone who is pregnant, breastfeeding, or at risk of a blocked bowel.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I am waiting for planned surgery to remove bowel cancer, at least 20 days away.
My BMI is 28 or higher (or 25 or higher if from a Black, Asian, or ethnic minority background).
I have not lost 10% or more of my weight in the last six months.
I do not have a soy allergy, type 1 diabetes, or severe kidney or heart disease.

Answer every question to see your result.

What does participation involve?

If you decide to join, a computer will randomly place you into one of two groups. You have an equal chance of being in either group. If you are in the usual care group, your treatment carries on exactly as planned by your hospital team. If you are in the weight-loss group, you will replace your normal meals with nutritious soups and shakes for three to four weeks before your operation, supported by weekly catch-ups with a dietitian.

Both groups will have routine health checks, including measurements to track weight and muscle health. The research team will monitor how you recover for 30 days after your operation. You may also be invited to an interview to share your thoughts about taking part. In total, your active involvement will last from a few weeks before your surgery until about one month after it.

Potential risks and benefits

If you are in the diet group, losing weight may improve your blood sugar levels and could lower your risk of problems after surgery, though this cannot be guaranteed. Everyone taking part helps doctors learn how best to support future bowel cancer patients. The diet replacement products are nutritionally complete, but some people experience mild, short-term side effects such as constipation, headaches, or tiredness as their body adjusts. Taking part is completely up to you, and you can stop at any time without your regular NHS cancer care being affected.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oxford University Hospitals NHS Foundation Trust
City only
Oxford, England
Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
Royal Devon University Healthcare NHS Foundation Trust
City only
Exeter, England
Dorset County Hospital NHS Foundation Trust
City only
Dorchester, England
University Hospitals Dorset NHS Foundation Trust
City only
Poole, England
North West Anglia NHS Foundation Trust
Unverified
Peterborough, England
University Hospitals of Derby and Burton NHS Foundation Trust
Unverified
Derby, England

Common questions

Will taking part delay my cancer surgery?

No. The diet programme is designed to fit into the standard three-to-four-week waiting window between your clinic visits and your planned operation.

Can I choose which group I am in?

No. A computer assigns you to either the diet programme or usual care by chance. This makes the comparison fair and scientifically reliable.

Will I feel hungry on the soup and shake diet?

You may feel hungry for the first few days, but most people find their appetite settles quickly. The meal replacements contain all the vitamins and nutrients your body needs.

What happens if I find the diet too difficult to stick to?

You will have weekly support from a dietitian to help you through any challenges. If you feel you cannot carry on, you can stop the diet at any point.

Do I have to pay for the meal replacements?

No. All study soups, shakes, and dietitian appointments are provided free of charge as part of the research trial.

How to find out more

CARE trial team CARE trial team

care@nds.ox.ac.uk 441865617767 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.