跳至主要内容
临床试验/NCT02385617
NCT02385617已完成不适用

Food Intake and Gut Hormone Release in Patients in Cancer Remission Who Have Undergone Upper Gastrointestinal Surgery

St. James's Hospital, Ireland2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Double blind single dose placebo-octreotide crossover

干预措施: Octreotide (Drug)

Esophagectomy

Experimental

Double blind single dose placebo-octreotide crossover

干预措施: Placebo (Drug)

Total gastrectomy

Experimental

Double blind single dose placebo-octreotide crossover

干预措施: Octreotide (Drug)

Total gastrectomy

Experimental

Double blind single dose placebo-octreotide crossover

干预措施: Placebo (Drug)

Control - no surgery

Active Comparator

Double blind single dose placebo-octreotide crossover

干预措施: Octreotide (Drug)

Control - no surgery

Active Comparator

Double blind single dose placebo-octreotide crossover

干预措施: Placebo (Drug)

Pancreaticoduodenectomy

Experimental

Double blind single dose placebo-octreotide crossover

干预措施: Octreotide (Drug)

Pancreaticoduodenectomy

Experimental

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

发起方
St. James's Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jessie A Elliott

Surgical Research Fellow

St. James's Hospital, Ireland

研究点 (2)

Loading locations...

相似试验