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

在低收入国家进行营养干预改善癌症手术后结局的整群随机试验的可行性

• 批准号: MR/S014527/1
• 负责人: Ewen Harrison
• 金额: $ 25.76万
• 依托单位: University of Edinburgh
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2018
• 资助国家: 英国
• 起止时间: 2018 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FS014527%2F1
• 关键词: Feasibility; cluster; randomised; trial; nutritional

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.

问题：对于许多类型的癌症，高质量的手术是唯一的治疗方法。在低收入国家尤其如此，因为这些国家可能无法提供化疗或放疗等治疗。手术顺利是很重要的。当并发症发生时，长期结果更糟，一些患者会死亡。人们越来越认识到，在手术前促进患者的健康可以大大提高手术成功的机会。当然，必须在手术和切除癌症的紧迫性与花时间改善病人健康的愿望之间取得平衡。癌症通常会导致体重极度减轻，在许多国家，这种情况是在原有营养不良的基础上发生的。问题：在手术前对患者进行营养补充剂的强化治疗是否有益？来自高收入国家的研究表明，这是可能的，在低收入国家的好处可能更大。团队：我们是一个完善的团队，致力于改善全球的外科护理。来自低收入和中等收入国家的外科医生在研究中心得到支持，并制定自己的研究议程。癌症手术中的营养已被确定为高度优先领域。我们的团队拥有使这项工作所需的广泛技能。我们目前的工作：我们正在收集世界各地接受癌症手术的患者的数据。这是同类研究中规模最大的一次，在100个国家进行。这些信息将使我们能够以一种以前不可能的方式找出营养不良和手术结果之间的关系。但我们真正想做的是想出一个解决方案。这项拨款申请是为了弥补我们目前的观察性研究和手术前治疗患者的试验之间的差距。我们拥有丰富的经验，目前正在启动ESTCON试验，研究在低收入国家减少手术后伤口感染的措施。未来拟定试验：我们希望在低收入和中等收入国家进行一项大型研究，为接受癌症手术的患者提供营养补充剂（有时称为即食治疗食品）。然后，我们将衡量它是否会导致更少的并发症和更好的手术后结果。在这之前，我们需要做三件事。首先，我们需要找到一种在低收入国家筛查营养不良患者的好方法。这是为了确定那些可能从治疗中受益最多的人。人们会认为这是容易的和既定的，但事实并非如此。需要开发或调整简单但准确的营养不良筛查方法，可供护士或医生用于接受手术的患者。其次，我们需要找到合适的产品。这需要满足特定的营养需求，但必须是廉价的，可持续的，最好是当地采购的。我们将与公司，专家，患者和临床医生合作，以找到最好的方法。第三，我们需要确保实际上可以进行审判。我们会问一些务实的问题，比如，我们的合作医院是否有足够数量的患者可以参加？他们能吃营养补充剂吗？出院后医院是否与患者接触，以确保我们知道他们发生了什么？确定可行性和规划所确定的任何问题，是确保成功的研究，如这是必不可少的。好处：我们建议在我们的网络（加纳，赞比亚，巴基斯坦和菲律宾）的一个小区域执行这一初步工作，但研究承诺巨大的好处超越这一点。关注手术前的健康和营养不良等问题对于改善全球癌症手术的结果至关重要。

项目成果

Impact of malnutrition on early outcomes after cancer surgery: an international, multicentre, prospective cohort study

• DOI: 10.1016/s2214-109x(22)00550-2
• 发表时间: 2023-02-14
• 期刊: LANCET GLOBAL HEALTH
• 影响因子: 34.3
• 作者: Riad, Aya M.;GlobalSurg Collaborative, N. I. H. R. Global Health Unit on Global;Harrison, Ewen M.
• 通讯作者: Harrison, Ewen M.

Malnutrition and nutritional screening in patients undergoing surgery in low and middle income countries: A systematic review

低收入和中等收入国家接受手术的患者的营养不良和营养筛查：系统评价

• DOI: 10.1002/crt2.55
• 发表时间: 2022
• 期刊: JCSM Clinical Reports
• 作者: Jones D

The impact of preoperative oral nutrition supplementation on outcomes in patients undergoing gastrointestinal surgery for cancer in low- and middle-income countries: a systematic review and meta-analysis.

• DOI: 10.1038/s41598-022-16460-4
• 发表时间: 2022-07-21
• 期刊: SCIENTIFIC REPORTS
• 影响因子: 4.6
• 作者: Knight, Stephen R.;Qureshi, Ahmad U.;Drake, Thomas M.;Lapitan, Marie Carmela M.;Maimbo, Mayaba;Yenli, Edwin;Tabiri, Stephen;Ghosh, Dhruva;Kingsley, Pamela A.;Sundar, Sudha;Shaw, Catherine;Valparaiso, Apple P.;Bhangu, Aneel;Brocklehurst, Peter;Magill, Laura;Morton, Dion G.;Norrie, John;Roberts, Tracey E.;Theodoratou, Evropi;Weiser, Thomas G.;Burden, Sorrel;Harrison, Ewen M.
• 通讯作者: Harrison, Ewen M.

A Qualitative Exploration of Nutrition Screening, Assessment and Oral Support Used in Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries.

• DOI: 10.3390/nu14040863
• 发表时间: 2022-02-18
• 期刊: Nutrients
• 影响因子: 5.9
• 作者: Sowerbutts AM;Knight SR;Lapitan MCM;Qureshi AU;Maimbo M;Yenli EMT;Tabiri S;Ghosh D;Kingsley PA;Sundar S;Shaw CA;Valparaiso A;Alviz CA;Bhangu A;Theodoratou E;Weiser TG;Harrison EM;Burden ST
• 通讯作者: Burden ST