NCT04112836

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 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
6 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

September 30, 2019

Last Update Submit

October 14, 2019

Conditions

Pancreatic CancerExocrine Pancreatic InsufficiencyMetastatic Pancreatic CancerChemotherapyMalnutritionLocally Advanced Malignant Neoplasm

Keywords

pancreatic cancerlocally advancedmetastaticnutritional statusexocrine pancreatic insufficiencychemotherapydose-intensity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Percent of patients with chemotherapy-related toxicity in each group

    12 weeks after the diagnosis

  • Survival at 6 months

    12 weeks after the diagnosis, 6 months

  • Progression-free survival

    6 months

  • Quality of Life (EORTC) QLQ-PAN26 scale

    12 weeks after the diagnosis

  • Number of hospitalizations

    12 weeks after the diagnosis

  • +1 more secondary outcomes

Study Arms (2)

Normal nutritional status

Patients, fulfilled inclusion criteria with Mini-Nutritional Assessment score of 24-30 points.

Malnourished

Patients, fulfilled inclusion criteria with Mini-Nutritional Assessment score of fewer than 17 points.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with unresectable locally advanced or metastatic PDAC

You may qualify if:

  • 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.

You may not qualify if:

  • poor performance status (Eastern Cooperative Oncology Group scale (ECOG) ≥ 3);
  • pregnancy;
  • surgery for PDAC in the past and developed progression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

IRCCS San Raffaele Scientific Institute

Milan, Italy

RECRUITING

Clinical Emergency Hospital Bucharest

Bucharest, Romania

RECRUITING

A.S. Loginov Moscow Clinical Scientific Center

Moscow, Russia

RECRUITING

University Clinic "Dr. Dragisa Misovic-Dedinje"

Belgrade, Serbia

NOT YET RECRUITING

University of Belgrade

Belgrade, Serbia

NOT YET RECRUITING

Alicante University General Hospital

Alicante, Spain

NOT YET RECRUITING

University Hospital of Santiago de Compostela

Santiago de Compostela, Spain

NOT YET RECRUITING

Istanbul University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Kiriukova M, de la Iglesia Garcia D, Panic N, Bozhychko M, Avci B, Maisonneuve P, de-Madaria E, Capurso G, Sandru V. Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer. Front Med (Lausanne). 2020 Sep 3;7:495. doi: 10.3389/fmed.2020.00495. eCollection 2020.

    PMID: 33015088DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsExocrine Pancreatic InsufficiencyMalnutritionNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNutrition DisordersNutritional and Metabolic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mariia Kiriukova, MD

    Moscow Clinical Scientific Center

    STUDY CHAIR

Central Study Contacts

Gabriele Capurso, MD, PhD

CONTACT

+39 02 26436548capurso.gabriele@hsr.it

Enrique de Madaria, MD, PhD

CONTACT

madaria@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 2, 2019

Study Start

March 15, 2019

Primary Completion

June 1, 2020

Study Completion

August 1, 2020

Last Updated

October 16, 2019

Record last verified: 2019-10

Locations

IT(1)SE(2)RU(1)TU(1)RO(1)ES(2)