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Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer

NCT04112836 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 186

Last updated 2019-10-16

No results posted yet for this study

Summary

Malnutrition and cachexia are common in patients with advanced pancreatic ductal adenocarcinoma (PDAC) and have a significant influence on the tolerance and response to treatments. If timely identified, malnourished PDAC patients could be treated to increase their capacity to complete the planned treatments and therefore, possibly, improve their efficacy.

The aim of the study is to assess the impact of nutritional status, pancreatic exocrine insufficiency (PEI), and other clinical factors on patient outcomes in patients with advanced PDAC.

The nutritional status will be determined by means of Mini-Nutritional Assessment score and laboratory blood tests. PEI will be defined as the presence of typical symptoms and/or reduced fecal elastase. Analysis: chemotherapy dosing over the first 12 weeks of therapy (i.e. percent of chemotherapy received in the first 12 weeks, as defined above) PAC-MAIN will provide insights on the role of malnutrition and PEI in outcomes of PDAC.

Conditions

Sponsors & Collaborators

  • University of Santiago de Compostela

    collaborator OTHER

  • University Clinic Dr Dragisa Misovic-Dedinje

    collaborator OTHER

  • University of Belgrade

    collaborator OTHER

  • Hospital General Universitario de Alicante

    collaborator OTHER

  • Istanbul University

    collaborator OTHER

  • European Institute of Oncology

    collaborator OTHER

  • IRCCS San Raffaele

    collaborator OTHER

  • Bucharest Emergency Hospital

    collaborator OTHER

  • Moscow Clinical Scientific Center

    lead OTHER

Principal Investigators

  • Mariia Kiriukova, MD · Moscow Clinical Scientific Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2020-06-30
Completion
2020-08-31

Countries

  • Italy
  • Romania
  • Russia
  • Serbia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04112836 on ClinicalTrials.gov