Clinical trial · Observational
Trial Comparing Parenteral Nutrition (PN) Using Eurotubes® vs. 2/3-chamber Bags in Subjects With Solid Tumors Requiring PN (PEKANNUSS)
Open-label, Randomized, Multicenter, Phase IV Trial Comparing Parenteral Nutrition Using Eurotubes® vs. Traditional 2/3-chamber Bags in Subjects With Metastatic or Localized Solid Tumors Requiring Parenteral Nutrition - The PEKANNUSS Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment
Summary
Brief summary (as posted)
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 using either 2/3-chamber bags or Eurotubes®, the latter either with or without reduced glucose. The main goal of the trial is to compare the frequency of self-administered parenteral nutrition at home (autonomy rate).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parenteral Nutrition 2/3 chamber Bag | Device | — | UNRESOLVED |
| Parenteral Nutrition Bag Eurotube | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Standard Low Glucose Parenteral Nutrition using Eurotubes®
- description
- Patients receive standard PN reduced in glucose in Eurotubes®.
- interventionNames
- Device: Parenteral Nutrition Bag Eurotube
- label
- Standard Parenteral Nutrition using Eurotubes®.
- description
- Patients receive standard PN in Eurotubes®.
- interventionNames
- Device: Parenteral Nutrition Bag Eurotube
- label
- Standard Parenteral Nutrition using 2/3-chamber bags
- description
- Patients receive PN according to the routine used by the participating site.
- interventionNames
- Device: Parenteral Nutrition 2/3 chamber Bag
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically confirmed metastatic or localized solid tumor. Perioperative setting of HPN is allowed if HPN is planned for a duration of ≥ 2 months 3. ECOG performance status of 0, 1, 2 or 3 4. Indication for PN (the subject needs a PN independent of the trial) 5. PN planned for 3 or more days per week 6. Negative pregnancy test in women of childbearing potential 7. Willingness to perform double-barrier contraception during study for women of childbearing potential 8. Willingness to maintain a study diary 9. Life expectancy \> 3 months 10. Written informed consent Exclusion Criteria: 1. \> 4 weeks of consecutive (3 ≥ days per week) parenteral nutrition in the last 3 months prior to study enrolment 2. 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 3. Current catheter related infection at baseline 4. Pregnancy or breastfeeding 5. Known hypertriglyceridemia ≥ CTCAE grade 3 6. Unable or unwilling to provide written informed consent and to comply with the study protocol 7. Uncontrolled diabetes mellitus 8. Congestive heart failure NYHA ≥ 3 9. Renal insufficiency GFR \< 30 ml/min 10. Uncontrolled infection 11. Liver insufficiency
References
Publications (1)
- DERIVEDGoetze TO, Hofheinz RD, Roetzer I, Blau W, Zander T, Luley KB, Ivanyi P, Groschek M, Kreiss-Sender J, Baur C, Wolff T, Wenning B, Behringer D, Weissinger F, Kunitz A, Tschechne B, Decker-Baumann C, Frank M, Wohn L, Riedel J, Sookthai D, Schaaf M, Al-Batran SE, Haag GM; AIO Study Group. Individually compounded multi-chamber vs. standardized parenteral nutrition bags in solid tumors-A randomized clinical trial (IKF-010). Clin Nutr ESPEN. 2025 Oct;69:106-114. doi: 10.1016/j.clnesp.2025.06.040. Epub 2025 Jun 24. PMID 40571097