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临床试验/NCT01382667
NCT01382667已完成不适用

Evaluation of Dyspeptic Symptoms in Oncological Frail Patients With Extraintestinal Cancer in Chemotherapy. Assessment of Circulating Levels of Glucagon-like Peptide 2 (GLP-2) in Relation to Mucositis

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
GLP-2 plasma levels in cancer patients

研究概览

简要总结

The specific aim of the study is to investigate the relationship between the development of dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI peptides (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm well controlled for emesis.

详细描述

The complications of anticancer treatment threaten the effectiveness of therapy because they lead to dose reduction, increase healthcare costs, and impair patients' quality of life. Gastrointestinal (GI) symptoms are the most frequent side effects of antineoplastic chemotherapy behind bone-marrow depression, with nausea and vomiting representing the mainly referred ones.

Gastrointestinal (GI) mucositis, which represents injury of the rest of the alimentary tract beyond oral mucositis, is becoming recognized increasingly as a toxicity associated with many standard-dose chemotherapy regimens. Although clinicians consider them "minor complaints", many patients (40-100%) treated with chemotherapy and/or exposed to ionizing radiation suffer from such a disease. After chemotherapy, GI mucositis is most prominent in the small intestine, but it also occurs in the esophagus, stomach, and large intestine. The GI symptoms related to mucositis mimic those from other GI disease (such as dyspepsia, reflux disease or abdominal pain and diarrhea). Alimentary tract mucositis increases morbility and mortality and contribute to rising health care cost.

The comprehension of pathophysiology will shed light on the rationale for targeting specific pathways and so for the use of specific agents for prevention and treatment. Since the role of chemotherapy in the onset of GI motility disorders in addition to minor GI complaints has not been clarified yet. Understanding the pathophysiology of mucositis, its measures and scores, are essential for progress in research and care direct at this common side-effect of anticancer therapy. Currently, there is not strong evidence to support a recommendation for and against the use of certain agents (mucosal surface protectants, antiinflammatory or antimicrobial agents, growth factors, etc).

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with newly diagnosed cancer (lung and breast cancer),
  • Patients currently free of active disease

排除标准

  • History of cerebral edema, primary and secondary brain neoplasm with signs and symptoms of raised intracranial pressure and/or brain metastases,
  • Signs of marked hepatic or renal dysfunction, cardiac failure
  • Signs of dyspepsia, peptic ulcer, gastric surgery or prior diagnosis of other cancer
  • Administration of drugs interfering with GI motility (i.e. antisecretory, prokinetic, or antibiotic drugs) as well as the exposition to radiotherapy, four weeks prior to the examination
  • Referred episode of nausea of any severity within 24 h prior to antiemetic therapy, if they had experienced vomiting in the previous 24 h,
  • Pregnancy or lactating
  • Concomitant administration of agents known to have significant antiemetic activity, including benzodiazepines and other corticosteroids

结局指标

主要结局

GLP-2 plasma levels in cancer patients

时间窗: 21 days

Evaluation of plasma levels of GLP-2 in patients with extraintestinal cancer before and after chemotherapy.

次要结局

  • Cancer associated dyspepsia syndrome, mucositis and GLP-2 plasma levels(21 days)

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Russo

MD

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

研究点 (1)

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