- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105777
Trial Comparing Parenteral Nutrition (PN) Using Eurotubes® vs. 2/3-chamber Bags in Subjects With Solid Tumors Requiring PN (PEKANNUSS) (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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Thorsten Goetze
- Phone Number: +49 (0) 69 / 76 01 - 4420
- Email: Goetze.Thorsten@KHNW.DE
Study Contact Backup
- Name: Johanna Riedel
- Email: riedel.johanna@ikf-khnw.de
Study Locations
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-
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Berlin, Germany
- Berlin Spandau Vivantes Klinikum
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Bielefeld, Germany
- Evangelisches Klinikum Bethel gGmbh, Bielefeld
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Bochum, Germany
- Augusta Kranken-Anstalt gGmbH
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Braunschweig, Germany
- Praxis Braunschweig
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Frankfurt, Germany, 60488
- Krankenhaus Nordwest
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Hamburg, Germany
- OncoResearch Lerchenfeld GmbH
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Hannover, Germany, 30625
- Medizinische Hochschule Hannover
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Heidelberg, Germany, 69120
- NCT Heidelberg
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Köln, Germany
- Uniklinikum Köln
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Lübeck, Germany, 23538
- Universitätsklinikum Schleswig-Holstein
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Mannheim, Germany
- Universitätsmedizin Mannheim
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Meschede, Germany
- Klinikum Hochsauerland
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Neustadt Am Rübenberge, Germany
- MVZ Onko Medical GmbH Neustadt
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Stolberg, Germany
- Clinical Research Stolberg GmbH
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Wiesbaden, Germany
- Helios Dr. Horst Schmidt Kliniken Wiesbaden
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Standard Low Glucose Parenteral Nutrition using Eurotubes®
Patients receive standard PN reduced in glucose in Eurotubes®.
|
7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.
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Standard Parenteral Nutrition using Eurotubes®.
Patients receive standard PN in Eurotubes®.
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7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.
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Standard Parenteral Nutrition using 2/3-chamber bags
Patients receive PN according to the routine used by the participating site.
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Premixed 2/3-chamber bags which are eventually completed with other supplements shortly before administration by infusion into the bag.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patients' autonomy
Time Frame: up to 1 year
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative weight change
Time Frame: up to 1 year
|
Relative weight change determined at baseline and during study visits approx.
every four weeks after enrolment
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up to 1 year
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Relative change of albumin and CRP
Time Frame: up to 1 year
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Relative change of albumin and CRP levels measured at baseline and during regular study visits
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up to 1 year
|
Overall survival
Time Frame: up to 4 years
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Overall survival (OS) defined as the time from randomization to death from any cause
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up to 4 years
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Incidence and severity of adverse events
Time Frame: up to 12 months
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incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 5.0 criteria as assessed every 4 weeks
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up to 12 months
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Patient reported outcomes - Quality of life
Time Frame: up to 12 months
|
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".
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up to 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catheter related infections (CRI)
Time Frame: up to 12 months
|
Catheter related infections (CRI) defined as the presence of bacteraemia originating from the intravenous (port) catheter - Bacteraemia must be confirmed through a blood culture according to study site-specific routine, preferably through paired quantitative blood cultures or a culture of the catheter if the catheter is removed - OR any infections originating from the intravenous (port) catheter, requiring intravenous antibiotics OR infections in the intravenous (port) catheter, requiring intravenous antibiotics or antibiotics delivered to the catheter itself or catheter removal
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up to 12 months
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Catheter related complications
Time Frame: up to 12 months
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Catheter related complications such as line occlusions of catheter-related central venous thrombosis
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up to 12 months
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severe infections
Time Frame: up to 12 months
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Severe, NCI-CTC common toxicity criteria version 5.0 grade 3-5, infections including fever of unknown origin and other Adverse Events according to NCI-CTC common toxicity criteria version 5.0
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up to 12 months
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PN-Related Adverse Events (AEs)
Time Frame: up to 12 months
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PN-Related Adverse Events (AEs) during therapy
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up to 12 months
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hospitalizations
Time Frame: up to 12 months
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hospitalizations during therapy
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up to 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Thorsten Goetze, KHNW Frankfurt, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEKANNUSS
- AIO-LQ-0119/ass (Other Identifier: AIO (Arbeitsgemeinschaft Internistische Onkologie))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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