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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

18 Years
70 Years
Not Enrolling
Breast Cancer, Lung Cancer, Dyspepsia

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Trial Information

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

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).

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

GLP-2 plasma levels in cancer patients

Outcome Description:

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

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Caterina Clemente, ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Digestive Diseases IRCCS "S. de Bellis"


Italy: Ministry of Health

Study ID:




Start Date:

July 2011

Completion Date:

January 2012

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Dyspepsia
  • mucositis
  • dyspepsia
  • chemotherapy
  • GLP-2
  • questionnaire
  • Breast Neoplasms
  • Dyspepsia
  • Lung Neoplasms