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临床试验/NCT03377660
NCT03377660终止不适用

The Effect of Clinical Treatment for Unintentional Weight Loss on Food Reward and Appetitive Behaviour in Patients Who Have Lost >10% of Their Body Weight After Undergoing Curative Surgery for Oesophageal Cancer

Imperial College London1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
1
主要终点
Change in BOLD signal

研究概览

简要总结

The investigators aim to ascertain how food reward signals and eating behaviour relates to the gut-brain pathway in weight-losing patients after curative surgery for oesophageal cancer, and how this pathway responds to clinical treatment for this unintentional weight loss. The primary outcomes are the blood oxygen level dependent (BOLD) signal on functional MRI (fMRI), and the breakpoint during the progressive ratio task (PRT - a measure of eating behaviour), how these differ in response to multiple clinical treatment options, as well as how they relate to weight gain while on treatment.

详细描述

The incidence of cancer of the oesophagus (food pipe) is increasing. Improvements in treatment strategies have resulted in more people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with oesophageal cancer, but while surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Poor appetite, weight loss and nutritional impairment are common problems among patients who attain long-term cancer remission and cure after surgery.

A new clinic has been established to treat patients who are in remission but who have lost more than 10% of their body weight secondary to the effects of the surgery and struggling to regain weight. These patients will be treated as per standard of care with medications to aid weight gain.

The investigators are interested to conduct research into how the reward value of food changes during the clinical treatment pathway. The hypothesis is that there will be an increased reward response to food after medication use, the magnitude of which will correlate with weight gain. To assess this, patients who are already part of this clinic will be approached to have fMRI that can demonstrate changes in brain reward centres as well as a Progressive Ratio Task, which is a direct measure of appetitive behaviour. Changes in brain reward centre responses and appetitive behaviour will be correlated with changes in weight after pharmacotherapy. This may further inform future clinical protocols to provide improved precision medicine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of esophagectomy with gastric conduit reconstruction
  • Recurrence-free at least 12 months post-operatively
  • Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation
  • Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine

排除标准

  • Pregnancy, breastfeeding
  • Significant and persistent chemoradiotherapy and/or surgical complication
  • Other active malignancy
  • Exocrine pancreatic insufficiency detected using fecal elastase
  • Uncontrolled diabetes mellitus
  • Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent
  • Severe dysphagia
  • Other disease or medication which may impact gut hormone physiology
  • History of significant food allergy, certain dietary restrictions
  • Any definite contraindication to somatostatin analogue administration
  • Claustrophobia, or any absolute contraindication to MRI scanning
  • Metallic implants, precluding fMRI

结局指标

主要结局

Change in BOLD signal

时间窗: Before and after 4 weeks of clinical treatment

Measure of food reward on fMRI

Change in breakpoint at PRT

时间窗: Before and after 4 weeks of clinical treatment

Measure of drive to eat

次要结局

  • Correlation of weight change during treatment with PRT breakpoint changes(Before and after 4 weeks of clinical treatment)
  • Correlation of weight change during treatment with BOLD signal changes(Before and after 4 weeks of clinical treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carel Le Roux

Professor of experimental pathology, Reader in investigative science

Imperial College London

研究点 (1)

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