Plasma Levels of Glucagon-like Peptide-2 and Dyspepsia in Patients With Extraintestinal Cancer During Chemotherapy

Completed

• Conditions: Dyspepsia; Breast Cancer; Lung Cancer

• Registration Number: NCT01382667
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GLP-2 plasma levels in cancer patients	21 days	Evaluation of plasma levels of GLP-2 in patients with extraintestinal cancer before and after chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Cancer associated dyspepsia syndrome, mucositis and GLP-2 plasma levels	21 days	Evaluation of the symptom profile related to CADS (cancer associated dyspepsia syndrome) before and after the first cycle of chemotherapy.; Assessment of possible relations between mucositis score, gastrointestinal symptom score and GLP-2 plasma levels.

Trial Locations

Locations (1)

National Institute for Digestive Diseases IRCCS "S. de Bellis"; 🇮🇹 Castellana Grotte, Bari, Italy