Trial Comparing Parenteral Nutrition (PN) Using Eurotubes® vs. 2/3-chamber Bags in Subjects With Solid Tumors Requiring PN (PEKANNUSS)

NCT04105777 | Terminated DMC

• 2 other identifiers: PEKANNUSSAIO-LQ-0119/ass
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 15

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 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

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• patients' autonomy

  Rate of self-administered parenteral nutrition at home (autonomy rate), defined as administration without nursing service assistance, as documented within the patient's study diary and calculated as the number of patients with autonomy divided by the total number of patients in the respective arm. Autonomy - as relevant for the primary endpoint - is achieved if the patient self-administers 70% or more of her/his total administrations (Note: Help of family members or other personal caregivers accounts for self-administration).

  up to 1 year

Secondary Outcomes (5)

• Relative weight change

  up to 1 year

• Relative change of albumin and CRP

  up to 1 year

• Overall survival

  up to 4 years

• Incidence and severity of adverse events

  up to 12 months

• Patient reported outcomes - Quality of life

  up to 12 months

Other Outcomes (5)

• Catheter related infections (CRI)

  up to 12 months

• Catheter related complications

  up to 12 months

• severe infections

  up to 12 months

Study Arms (3)

Standard Low Glucose Parenteral Nutrition using Eurotubes®

Patients receive standard PN reduced in glucose in Eurotubes®.

Device: Parenteral Nutrition Bag Eurotube

Standard Parenteral Nutrition using Eurotubes®.

Patients receive standard PN in Eurotubes®.

Device: Parenteral Nutrition Bag Eurotube

Standard Parenteral Nutrition using 2/3-chamber bags

Patients receive PN according to the routine used by the participating site.

Device: Parenteral Nutrition 2/3 chamber Bag

Interventions

Parenteral Nutrition Bag Eurotube DEVICE

7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.

Standard Low Glucose Parenteral Nutrition using Eurotubes®; Standard Parenteral Nutrition using Eurotubes®.

Parenteral Nutrition 2/3 chamber Bag DEVICE

Premixed 2/3-chamber bags which are eventually completed with other supplements shortly before administration by infusion into the bag.

Standard Parenteral Nutrition using 2/3-chamber bags

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with metastatic or localized solid tumors requiring parenteral nutrition

You may qualify if:

• 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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead

Study Sites (15)

Berlin Spandau Vivantes Klinikum

Berlin, Germany

Location

Evangelisches Klinikum Bethel gGmbh, Bielefeld

Bielefeld, Germany

Location

Augusta Kranken-Anstalt gGmbH

Bochum, Germany

Location

Praxis Braunschweig

Braunschweig, Germany

Location

Uniklinikum Köln

Cologne, Germany

Location

Krankenhaus Nordwest

Frankfurt, 60488, Germany

Location

OncoResearch Lerchenfeld GmbH

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

NCT Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Universitätsmedizin Mannheim

Mannheim, Germany

Location

Klinikum Hochsauerland

Meschede, Germany

Location

MVZ Onko Medical GmbH Neustadt

Neustadt am Rübenberge, Germany

Location

Clinical Research Stolberg GmbH

Stolberg, Germany

Location

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, Germany

Location

Related Publications (1)

• Goetze 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 DERIVED

Study Officials

• Thorsten Goetze

  KHNW Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 26, 2019
• Study Start: January 30, 2020
• Primary Completion: November 23, 2022
• Study Completion: January 31, 2023
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (15)