Status:
UNKNOWN
Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer
Lead Sponsor:
Moscow Clinical Scientific Center
Collaborating Sponsors:
University of Santiago de Compostela
University Clinic Dr Dragisa Misovic-Dedinje
Conditions:
Pancreatic Cancer
Exocrine Pancreatic Insufficiency
Eligibility:
All Genders
18+ years
Brief 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 identifie...
Detailed Description
Investigators hypothesize that malnutrition has an adverse impact on the clinical course of patients with advanced PDAC treated with chemotherapy. Aims: To investigate the association between the nu...
Eligibility Criteria
Inclusion
- age ≥ 18 years;
- histological diagnosis of PDAC within one month from recruitment to the study;
- radiological diagnosis of the advanced stage not suitable for upfront surgical resection (either locally advanced or metastatic) within 5 weeks from recruitment to the study;
- data on the variables and the outcomes of interest are available;
- a written consent to participate in the study;
- being planned for chemotherapy;
- no past history of anticancer treatment.
Exclusion
- poor performance status (Eastern Cooperative Oncology Group scale (ECOG) ≥ 3);
- pregnancy;
- surgery for PDAC in the past and developed progression.
Key Trial Info
Start Date :
March 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT04112836
Start Date
March 15 2019
End Date
August 1 2020
Last Update
October 16 2019
Active Locations (8)
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1
IRCCS San Raffaele Scientific Institute
Milan, Italy
2
Clinical Emergency Hospital Bucharest
Bucharest, Romania
3
A.S. Loginov Moscow Clinical Scientific Center
Moscow, Russia
4
University Clinic "Dr. Dragisa Misovic-Dedinje"
Belgrade, Serbia