Status:
TERMINATED
Trial Comparing Parenteral Nutrition (PN) Using Eurotubes® vs. 2/3-chamber Bags in Subjects With Solid Tumors Requiring PN (PEKANNUSS)
Lead Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Brief Summary
Patients with inoperable metastatic or localized solid tumors who have an indication for parenteral nutrition will be enrolled and receive standard parenteral nutrition according to randomization usin...
Detailed Description
This is an open-label, randomized, multicenter, investigator-initiated, phase IV trial. A total number of 216 patients will be enrolled. Patients will be stratified according to ECOG (0-1 vs. 2 vs. 3...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histologically confirmed metastatic or localized solid tumor. Perioperative setting of HPN is allowed if HPN is planned for a duration of ≥ 2 months
- ECOG performance status of 0, 1, 2 or 3
- Indication for PN (the subject needs a PN independent of the trial)
- PN planned for 3 or more days per week
- Negative pregnancy test in women of childbearing potential
- Willingness to perform double-barrier contraception during study for women of childbearing potential
- Willingness to maintain a study diary
- Life expectancy \> 3 months
- Written informed consent
Exclusion
- \> 4 weeks of consecutive (3 ≥ days per week) parenteral nutrition in the last 3 months prior to study enrolment
- Participation in another interventional clinical trial that could influence the endpoints of this trial or planned participation in such a study at the same time as this study is active (participation in other trials is possible in the follow up time for OS). The study is active, if the patients receive study treatment (PN), did not discontinue the trial for other reasons, and is still within the 12 months active study period
- Current catheter related infection at baseline
- Pregnancy or breastfeeding
- Known hypertriglyceridemia ≥ CTCAE grade 3
- Unable or unwilling to provide written informed consent and to comply with the study protocol
- Uncontrolled diabetes mellitus
- Congestive heart failure NYHA ≥ 3
- Renal insufficiency GFR \< 30 ml/min
- Uncontrolled infection
- Liver insufficiency
Key Trial Info
Start Date :
January 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04105777
Start Date
January 30 2020
End Date
January 31 2023
Last Update
January 6 2025
Active Locations (15)
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1
Berlin Spandau Vivantes Klinikum
Berlin, Germany
2
Evangelisches Klinikum Bethel gGmbh, Bielefeld
Bielefeld, Germany
3
Augusta Kranken-Anstalt gGmbH
Bochum, Germany
4
Praxis Braunschweig
Braunschweig, Germany