Clinical trial · Observational
Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Exocrine Pancreatic Insufficiency | — | UNRESOLVED | — |
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Malnutrition | — | UNRESOLVED | — |
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Normal nutritional status
- description
- Patients, fulfilled inclusion criteria with Mini-Nutritional Assessment score of 24-30 points.
- label
- Malnourished
- description
- Patients, fulfilled inclusion criteria with Mini-Nutritional Assessment score of fewer than 17 points.
Primary outcomes (2)
- measure
- Percent of standard chemotherapy dose delivered
- timeFrame
- 12 weeks after the diagnosis
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * poor performance status (Eastern Cooperative Oncology Group scale (ECOG) ≥ 3); * pregnancy; * surgery for PDAC in the past and developed progression.
References
Publications (1)
- DERIVEDKiriukova 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 33015088