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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04112836
Other study ID # 2/2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2019
Est. completion date August 2020

Study information

Verified date October 2019
Source Moscow Clinical Scientific Center
Contact Gabriele Capurso, MD, PhD
Phone +39 02 26436548
Email capurso.gabriele@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS San Raffaele Scientific Institute Milan
Romania Clinical Emergency Hospital Bucharest Bucharest
Russian Federation A.S. Loginov Moscow Clinical Scientific Center Moscow
Serbia University Clinic "Dr. Dragisa Misovic-Dedinje" Belgrade
Serbia University of Belgrade Belgrade
Spain Alicante University General Hospital Alicante
Spain University Hospital of Santiago de Compostela Santiago De Compostela
Turkey Istanbul University Istanbul

Sponsors (9)

Lead Sponsor Collaborator
Moscow Clinical Scientific Center Bucharest Emergency Hospital, European Institute of Oncology, Faculty of Medicine, Istanbul University, Hospital General Universitario de Alicante, IRCCS San Raffaele, University Clinic Dr Dragisa Misovic-Dedinje, University of Belgrade, University of Santiago de Compostela

Countries where clinical trial is conducted

Italy,  Romania,  Russian Federation,  Serbia,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of standard chemotherapy dose delivered Drug doses will be expressed in weight-based, body surface area (BSA)-based, Area Under the Curve (AUC) units or flat dose, according to standard dosing practice for a given drug or combination. For each drug in a regimen, the sum of the doses delivered during the first 12 weeks of therapy will be divided by the sum of the expected doses based on published standard schedule and dosing. The mean percent dose delivered of all drugs in a regimen will be reported as 'percent of standard chemotherapy dose delivered.' The investigators will use percent of standard chemotherapy dose delivered to estimate the overall relative dose delivered. 12 weeks after the diagnosis
Primary Percent of planned chemotherapy delivered Similarly, the sum of the doses delivered during the first 12 weeks of therapy will be divided by the sum of the expected doses based on each patient's starting chemotherapy dose, and the mean percent dose delivered for all drugs in a regimen will be reported as 'percent of planned chemotherapy delivered.' The investigators will use percent of planned chemotherapy dose delivered to quantify further dose reductions from starting dose and as an indicator of overall toxicity. 12 weeks after the diagnosis
Secondary Percent of patients with chemotherapy-related toxicity in each group 12 weeks after the diagnosis
Secondary Survival at 6 months 12 weeks after the diagnosis, 6 months
Secondary Progression-free survival 6 months
Secondary Quality of Life (EORTC) QLQ-PAN26 scale The pancreatic cancer module is designed for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy (Fitzsimmons et al., 1999a,b). The module comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes). The answers range is the following: not at all - 1 point, a little - 2 points, quite a bit - 3 points, very much - 4 points. Minimum score is 26, maximum is 106. The higher total score represents the worse quality of life. 12 weeks after the diagnosis
Secondary Number of hospitalizations 12 weeks after the diagnosis
Secondary Factors associated with the percent of chemotherapy received 12 weeks after the diagnosis
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