Food Intake and Gut Hormone Release in Patients in Cancer Remission Who Have Undergone Upper Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ad libitum calorie intake
研究概览
简要总结
Improvements to treatment strategies for patients upper gastrointestinal cancers have produced an increasing population of people who remain free from disease recurrence in the long term. Weight loss and nutritional problems are common among patients who attain long-term remission and cure after surgery for upper gastrointestinal cancers. However, the mechanisms underlying these problems are not well understood. In this study the investigators aim to determine whether reduced food intake after upper gastrointestinal surgery is caused by early satiety related to exaggerated post-prandial gut hormone responses.
This is a randomized, double-blind, placebo controlled, crossover study of the effect of 100μg octreotide SC on ad libitum food intake in patients free from complications or recurrence at least one year post-oesophagectomy, gastrectomy or pancreaticoduodenectomy. A comparator group of age, weight and gender matched subjects will be studied concurrently, and caloric intake and subjective symptom scores after administration of octreotide versus placebo among surgical and comparator subjects will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgical procedure: Two-stage, three-stage or transhiatal oesophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticodueodenectomy, or matched unoperated healthy controls
- •At least one year in remission post-resection (surgical groups)
排除标准
- •Pregnancy, breastfeeding
- •Significant and persistent chemoradiotherapy and/or surgical complication
- •Other previous upper gastrointestinal surgery
- •Significant dysphagia or odynophagia, unable to eat
- •Other disease or medications which may affect satiety gut hormone responses
- •Active and significant psychiatric illness including substance misuse
- •Cognitive or communication issues or any factors affecting capacity to consent to participation
- •History of significant food allergy, certain dietary restrictions
- •Confirmed or suspected residual or recurrent disease after surgery, second primary malignancy
- •Other reconstruction (eg colonic or jejunal interposition)
- •Any contraindication to octreotide administration
研究组 & 干预措施
Esophagectomy
Double blind single dose placebo-octreotide crossover
干预措施: Octreotide (Drug)
Esophagectomy
Double blind single dose placebo-octreotide crossover
干预措施: Placebo (Drug)
Total gastrectomy
Double blind single dose placebo-octreotide crossover
干预措施: Octreotide (Drug)
Total gastrectomy
Double blind single dose placebo-octreotide crossover
干预措施: Placebo (Drug)
Control - no surgery
Double blind single dose placebo-octreotide crossover
干预措施: Octreotide (Drug)
Control - no surgery
Double blind single dose placebo-octreotide crossover
干预措施: Placebo (Drug)
Pancreaticoduodenectomy
Double blind single dose placebo-octreotide crossover
干预措施: Octreotide (Drug)
Pancreaticoduodenectomy
Double blind single dose placebo-octreotide crossover
干预措施: Placebo (Drug)
结局指标
主要结局
Ad libitum calorie intake
时间窗: 1 hour
Total kcals consumed
次要结局
- Post-prandial satiety gut hormone response(2 hours)
- Subjective symptom scores(3 hours)
研究者
Dr Jessie A Elliott
Surgical Research Fellow
St. James's Hospital, Ireland
