Feasibility of a cluster randomised trial of a nutritional intervention to improve outcomes after cancer surgery in low-income countries

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THE PROBLEM: For many types of cancer, high quality surgery is the only cure. This is particularly true in low-income countries where treatments such as chemotherapy or radiotherapy may not be available. It is important that surgery goes well. When complications occur, longer term outcomes are worse, and some patients will die. It is increasingly recognised that boosting the health of patients before surgery can greatly improve the chances of success. Of course, a balance must be struck between the urgency to operate and remove the cancer and a desire to take time and improve a patient's health. Cancer often causes extreme weight loss and, in many countries, this occurs on top of pre-existing malnutrition. THE QUESTION: Would it be of benefit to intensively treat patients with nutritional supplements prior to surgery? Studies from high income countries suggest it could be, and the benefit may be even greater in low-income countries.THE TEAM: We are a well-established team working to improve surgical care worldwide. Surgeons from low- and middle-income countries are supported in Research Hubs and set their own research agenda. Nutrition in cancer surgery has been identified as an area of high priority. Our team has the broad set of skills required to make this work. OUR CURRENT WORK: We are gathering data on patients undergoing cancer surgery worldwide. It is the largest study of its kind and is taking place in 100 countries. This information will allow us to work out the relationship between malnutrition and the results of surgery in a way that hasn't been possible before. But what we really want to do is come up with a solution. This grant application is for funding to bridge the gap between our current observational study and a trial to treat patients prior to surgery. We have broad experience and are currently launching the FALCON trial, looking at steps to reduce wound infection after surgery in low-income countries. FUTURE PROPOSED TRIAL: We want to perform a large study in low- and middle-income countries giving a nutritional supplement (sometimes called ready-to-use therapeutic food) to patients undergoing cancer surgery. We will then measure whether it results in fewer complications and better outcomes after surgery. Before we can do that, we need to do three things. NEED FOR THIS PUMP PRIMING GRANT: First, we need to find a good way of screening patients for malnutrition in low-income countries. This is to identify those who may benefit most from a treatment. One would have thought that this would be easy and well-established, but it is not. Simple but accurate screening methods for malnutrition, which can be used by a nurse or a doctor for patients undergoing surgery, need to be developed or adapted. Second, we need to find an appropriate product. This needs to fulfil specific nutritional requirements but must be inexpensive, sustainable and ideally locally sourced. We will work with companies, experts, patients, and clinicians to find what is best. Third, we then need to make sure that a trial can actually be run. We will ask pragmatic questions such as, will there be a sufficient number of patients in our partner hospitals who can take part? Will they be able to take the nutritional supplement? Is the hospital in contact with patients after discharge to ensure we know what happens to them etc.? Determining the practicalities and planning for any problems identified is essential in ensuring the success of a study such as this.THE BENEFIT: We propose to perform this preliminary work in a small area of our network (Ghana, Zambia, Pakistan and the Philippines), but the research promises great benefits beyond this. Focusing on fitness prior to surgery and issues such as malnutrition will be essential in improving the outcomes of cancer surgery worldwide.