Centre for Dietetics Research (C-DIET-R), School of Human Movement Studies, The University of Queensland, St Lucia, Brisbane, QLD 4072, Australia ; Department of Nutrition and Dietetics, Royal Brisbane and Women's Hospital, Herston, Brisbane, QLD 4029, Australia.
Department of Nutrition and Dietetics, Royal Brisbane and Women's Hospital, Herston, Brisbane, QLD 4029, Australia.
BMC Nurs. 2014 Jul 1;13:17. doi: 10.1186/1472-6955-13-17. eCollection 2014.
Patients with head and neck cancer are at high risk of malnutrition and dysphagia. Enteral tube feeding via a gastrostomy or nasogastric tube is often required in response to dysphagia, odynophagia or side effects of treatment that lead to dehydration and/or weight-loss. A recent systematic review concluded that the optimal method of tube feeding remains unclear; however prophylactic gastrostomy, placed in anticipation of its use during and after treatment, is common practice, following a number of demonstrated benefits. However the majority of these studies have been undertaken in patients receiving radiotherapy alone. More recent studies in patient populations receiving concurrent chemoradiotherapy are showing that despite prophylactic gastrostomy placement significant weight loss still occurs, placing the patient at risk of the consequences of malnutrition. Therefore we set out to investigate innovative prophylactic nutrition support via the gastrostomy to optimise the nutritional outcomes of patients with head and neck cancer.
METHODS/DESIGN: Patients with head and neck cancer will be eligible for this single centre randomised controlled trial if they are identified for referral for a prophylactic gastrostomy using local guidelines. Patients will be excluded if they are: under the age of eighteen; pregnant; unable to give informed consent; or severely malnourished or moderately malnourished with significant dysphagia requiring a liquid or puree diet. All eligible patients who consent for the study will be allocated randomly to either the intervention or control group (usual care). The intervention group will commence prophylactic supplementary nutrition support via the gastrostomy immediately following placement compared to usual care where nutrition support is commenced via the gastrostomy when clinically indicated during treatment. Key outcome measures will be percentage weight loss, body composition, nutritional status and quality of life, measured at baseline and three months post treatment.
To our knowledge this is the first study to evaluate the effectiveness of early prophylactic tube feeding compared to commencement of feeding during treatment, as per current standard practice, in patients undergoing prophylactic gastrostomy prior to treatment for head and neck cancer.
This trial has been registered in the Australian New Zealand Clinical Trials registry as ACTRN12612000579897.
头颈部癌症患者存在发生营养不良和吞咽困难的高风险。为应对吞咽困难、疼痛或治疗引起的副作用（包括脱水和/或体重减轻），通常需要通过胃造口术或鼻胃管进行肠内管饲。最近的系统评价得出结论，最佳的管饲方法仍不明确；然而，出于治疗期间和之后使用的考虑，预防性胃造口术是一种常见的做法，因为这种方法具有一些已证实的益处。然而，这些研究中的大多数都是在接受单独放疗的患者中进行的。最近在接受同期放化疗的患者人群中进行的研究表明，尽管进行了预防性胃造口术，仍会发生显著的体重减轻，使患者面临营养不良的后果。因此，我们着手研究通过胃造口术进行创新的预防性营养支持，以优化头颈部癌症患者的营养结局。
方法/设计：如果根据当地指南确定患者需要进行预防性胃造口术，且符合条件，则患者有资格参加这项单中心随机对照试验。如果患者年龄小于 18 岁；怀孕；无法给予知情同意；或严重营养不良或中度营养不良且存在严重吞咽困难需要液体或纯饮食，则将被排除在外。所有符合条件且同意参加研究的患者将被随机分配到干预组或对照组（常规护理）。干预组将在胃造口术后立即开始预防性补充营养支持，而对照组则在治疗期间根据临床需要开始通过胃造口术进行营养支持。主要结局指标将是治疗后三个月时的体重减轻百分比、身体成分、营养状况和生活质量。
据我们所知，这是第一项评估在头颈部癌症患者接受预防性胃造口术前，与目前的标准实践中在治疗期间开始进行喂养相比，预防性早期管饲的有效性的研究。
这项试验已在澳大利亚和新西兰临床试验注册中心注册，注册号为 ACTRN12612000579897。
