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

Study Overview
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Brief Summary
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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 incidence of catheter-related infections as well as the frequency of self-administered parenteral nutrition at home (autonomy rate).

Detailed Description
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This is an open-label, randomized, multicenter, investigator-initiated, phase IV trial. A total number of 350 patients will be enrolled. Patients will be stratified according to ECOG (0-1 vs. 2 vs. 3), the modified Glasgow Prognostic Score (mGPS) (0-1 vs. 2) and whether the patient receives concurrent systemic anti-tumor treatment or not. In a first step, patients will be randomized in a 2:1 ratio to Arm A (Standard Parenteral Nutrition using Eurotubes®) or Arm B (Standard Parenteral Nutrition using 2/3-chamber bags). Patients in Arm A will be stratified again by the same criteria as listed above and randomized in a 1:1 ratio to Arm A-1 (Standard Low Glucose Parenteral Nutrition using Eurotubes®) or Arm A-2 (Standard Parenteral Nutrition using Eurotubes®). Within the study, the patient can receive PN for a maximum of 12 months after randomization as long as the PN is still indicated and deemed necessary by the investigator. Co-Primary objectives are to compare the incidence of catheter related infections and to compare the frequency of self-administered parenteral nutrition at home (HPN). Main secondary objectives are to compare the efficacy of parenteral nutrition (PN) in terms of body weight, C-reactive protein (CRP) and albumin levels, and overall survival (OS), to compare the Quality of life (QoL) by use of a modified HPN-PROQ questionnaire, to determine the frequency and duration of visits by the nursing service and to compare specified safety parameters. The HPN therapy plan determined at screening and any modifications and adjustments to this plan during the course of HPN treatment will be recorded. Anti-cancer treatment at the time of screening and any changes during the course of the HPN treatment period (e.g. type of treatment) will be documented. Monitoring of Adverse Events and medical device deficiencies will be performed at every visit. AEs will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. During the study the patient will maintain a study diary to document details of the administration of the HPN. A QoL questionnaire will be completed during regular study visits until EOT. After completion of study treatment, patients will enter the follow-up period. During this period, they will be followed approximately every 3 months for survival.

Official Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Device: Parenteral Nutrition Bag Eurotube
* Device: Parenteral Nutrition 2/3 chamber Bag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: > 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Low Glucose Parenteral Nutrition using Eurotubes®<br>Patients receive standard PN reduced in glucose in Eurotubes®. | Device: Parenteral Nutrition Bag Eurotube<br>* 7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.<br>|
| Standard Parenteral Nutrition using Eurotubes®.<br>Patients receive standard PN in Eurotubes®. | Device: Parenteral Nutrition Bag Eurotube<br>* 7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.<br>|
| Standard Parenteral Nutrition using 2/3-chamber bags<br>Patients receive PN according to the routine used by the participating site. | Device: Parenteral Nutrition 2/3 chamber Bag<br>* Premixed 2/3-chamber bags which are eventually completed with other supplements shortly before administration by infusion into the bag.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative weight change | Relative weight change determined at baseline and during study visits approx. every four weeks after enrolment | up to 1 year | 
| Relative change of albumin and CRP | Relative change of albumin and CRP levels measured at baseline and during regular study visits | up to 1 year | 
| Overall survival | Overall survival (OS) defined as the time from randomization to death from any cause | up to 4 years | 
| Incidence and severity of adverse events | incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 5.0 criteria as assessed every 4 weeks | up to 12 months | 
| Patient reported outcomes - Quality of life | Quality of life as measured by a modified HPN-PROQ questionnaire at baseline, at every visit and on EOT. For different types of questions, two scales are used, one is a 7-point-scale (range 1-7) with 1 meaning very bad, 7 excellent and the numbers in between the respective intermediate states. The second scale measures 10 cm. The patients will have to put a cross on the line at the place which corresponds best to their state of the past week. 0 indicates never or false and 10 daily or correct. | up to 12 months |