Not yet recruitingNAINTERVENTIONAL

Obesity Prevention in Children and Young People Treated for Acute Lymphoblastic Leukaemia with ALLTogether

Children diagnosed with leukaemia often become obese during their treatment, which can cause more health problems and make it harder for their medicine to work. The BREVARY study aims to find out if personalised diet and physical activity plans can help prevent this in children and young people receiving the ALLTogether leukaemia treatment. We'll divide participants into three groups: one with both diet and exercise plans, one with only a diet plan, and a control group receiving standard care. These plans will be made with families, considering their food tastes and finances. The study will help us understand if this approach can reduce obesity and improve overall health and the chances of successful treatment. We'll also check if a bigger study should be done.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Exeter

Enrolment target

Start

01 Apr 2025

Estimated completion

31 Dec 2029

Diet Intervention Physical Activity Intervention Standard Care Control

What is this study about?

When children and young people are treated for leukaemia, they often receive strong medicines, like chemotherapy and steroids. While these treatments are vital for saving lives, they can sometimes have side effects. One common side effect is that about half of these children might become overweight, or obese, during their treatment. This can happen because of increased hunger, cravings for certain foods, and not being able to be as active as usual.

Being obese during leukaemia treatment can make things harder. It can increase the chance of the cancer coming back, make treatment side effects worse, and even make it more difficult for the medicines to kill the leukaemia cells. This study, called BREVARY, is an important step to see if we can prevent obesity in these children while they're on the ALLTogether leukaemia trial. We want to find out if providing personalised healthy eating and activity plans, along with support, can help them stay healthy and improve their chances of a full recovery.

The main goals of BREVARY are to see if such a program can actually work for children with leukaemia, and if enough families would want to join and stick with it. If successful, this study could lead to a larger project specifically designed to reduce obesity, lessen side effects, and ultimately help more children survive leukaemia and live well after treatment. The information we gather will help us design the best possible support for these children.

Key takeaways

This study is testing ways to prevent obesity in children with leukaemia.
It involves personalised diet and exercise plans.
Participation could improve your child's health and treatment outcomes.
The study helps decide if a larger, more impactful program is possible.
You have the right to withdraw at any time.

Who may be eligible?

This study is looking for children and young people aged between 5 and 21 years old. To join, they must have recently been diagnosed with acute lymphoblastic leukaemia (which means they might be getting treatment for the first time or the cancer has come back) and be receiving care at either University Hospital Bristol and Weston NHS Foundation Trust or Hospital Infantil Universitario Nino Jesus in Madrid.

Crucially, all participants must be starting the ALLTogether treatment plan within two weeks of joining this study. This study is for those whose doctors are aiming to cure their leukaemia, not just to make them more comfortable.

Unfortunately, if a child is not on the ALLTogether treatment plan, or if their doctors are focusing on palliative care (which means making them comfortable rather than trying to cure the cancer), they wouldn't be able to join. Also, if medical staff believe it's not suitable for a child to take part for specific health reasons, they would be excluded.

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.

Is your child aged between 5 and 21 years?
Has your child been recently diagnosed with leukaemia (new or returning)?
Is your child being treated in Bristol or Madrid?
Will your child be starting the ALLTogether treatment within two weeks?
Is your child's treatment aiming for a cure, not just comfort?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the BREVARY study, your child will be put into one of three groups by chance, like drawing names from a hat. One group will get a personalised diet plan, another will get both a personalised diet plan and a physical activity plan, and the last group will receive the standard care they would normally get for their leukaemia.

The diet and exercise plans will be created together with your child and your family. These plans will consider your child's food preferences, cultural or religious needs, any side effects from their treatment, and what works for your family's budget. You'll receive support for these plans either online or during your regular hospital visits.

Throughout the study, we'll collect information about your child three times. This will include measurements like their weight, height, body fat, and how strong their muscles are. We'll also look at their diet and overall well-being. At the end of the study, we'll have a one-to-one chat with you and your child to hear about your experiences and get your feedback on the BREVARY programme.

Potential risks and benefits

Taking part in this study could potentially offer several benefits. Your child might receive personalised diet and activity support that could help manage their weight, reduce treatment side effects, and improve their overall health and well-being during leukaemia treatment. This could also help us understand how to improve future care for other children with leukaemia. As with any study, there's always a chance that the interventions might not help your child specifically, or that the extra appointments for measurements could be tiring. However, the personalised plans are designed to be safe and supportive. Remember, you can choose to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (2)

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

Hospital Infantil Universitario Nino Jesus
Verified postcode
Madrid, Spain
University Hospitals Bristol & Weston NHS Trust
Verified postcode
Bristol, United Kingdom

Common questions

What is leukaemia and why is preventing obesity important?

Leukaemia is a type of cancer that affects blood cells. Preventing obesity is important because being overweight during treatment can make side effects worse and potentially make the cancer harder to treat effectively.

What is the ALLTogether trial?

ALLTogether is the standard treatment plan currently used by the NHS for children with acute lymphoblastic leukaemia. This study runs alongside that treatment.

Will my child have to do intense exercise?

No, the physical activity plans will be personalised and safe for your child. They will be designed with their current fitness and strength in mind and created together with your family.

What happens if my child doesn't like the food in the diet plan?

The diet plans are co-created with your child and family, considering their personal food preferences, cultural needs, and any challenges like treatment side effects. The aim is to make it enjoyable and sustainable.

Can I leave the study at any time?

Yes, your participation is completely voluntary, and you can withdraw your child from the study at any point without it affecting their medical care or relationship with their healthcare team.

How to find out more

Raquel Revuelta Iniesta, PhD

r.revuelta-iniesta@exeter.ac.uk 0044 07715303535 Official trial record

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