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

8 november 2012 uppdaterad av: Francesco Russo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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 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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Faktisk)

70

Kontakter och platser

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Studieorter

    • Bari
      • Castellana Grotte, Bari, Italien, 70013
        • National Institute for Digestive Diseases IRCCS "S. de Bellis"

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Twenty-five patients who had undergone surgical ablation of the primitive tumour (lung and breast cancer) as definitive primary treatment and attending the Oncology Day Hospital of our Institute,and the IRCCS Oncologico of Bari will be enrolled. They had to be scheduled for adjuvant therapies associated with a standard dosage of antiserotoninergic drugs according to ESMO recommendations

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
GLP-2 and symptom evaluation
Before starting and at the end of the chemotherapy, along with a blood withdrawal for GLP-2 evaluation, a GSRS (gastrointestinal symptom rate scale) questionnaire will be filled by each patient to account for GI symptoms. In addition, minor complaints such as warm sensation after chemotherapy, susceptibility to nausea under specific condition, sweating and weakness will scored by visual analog score (VAS). Lastly, the NCI-CTC score for mucositis will be performed.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
GLP-2 plasma levels in cancer patients
Tidsram: 21 days
Evaluation of plasma levels of GLP-2 in patients with extraintestinal cancer before and after chemotherapy.
21 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cancer associated dyspepsia syndrome, mucositis and GLP-2 plasma levels
Tidsram: 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.

21 days

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Caterina Clemente, ScD, National Institute of Digestive Diseases IRCCS "S. de Bellis"

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2011

Primärt slutförande (Faktisk)

1 december 2011

Avslutad studie (Faktisk)

1 januari 2012

Studieregistreringsdatum

Först inskickad

24 juni 2011

Först inskickad som uppfyllde QC-kriterierna

24 juni 2011

Första postat (Uppskatta)

27 juni 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 november 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 november 2012

Senast verifierad

1 november 2012

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SRLP06

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