Solid TumorPEKANNUSSNCT04105777
Trial Comparing Parenteral Nutrition (PN) Using Eurotubes® vs. 2/3-chamber Bags in Subjects With Solid Tumors Requiring PN (PEKANNUSS)
An observational study of Solid Tumor, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 15 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Parenteral Nutrition Bag Eurotube and Parenteral Nutrition 2/3 chamber Bag
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 142 participants
- Where
- 15 sitesGermany
- Study dates
- 30 Jan 2020to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic or localized solid tumors requiring parenteral nutrition
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- > 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
Show all 11Show fewer
- Uncontrolled diabetes mellitus
- Congestive heart failure NYHA ≥ 3
- Renal insufficiency GFR < 30 ml/min
- Uncontrolled infection
- Liver insufficiency
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Berlin Spandau Vivantes Klinikum
Berlin
Evangelisches Klinikum Bethel gGmbh, Bielefeld
Bielefeld
Augusta Kranken-Anstalt gGmbH
Bochum
Praxis Braunschweig
Braunschweig
Uniklinikum Köln
Cologne
Krankenhaus Nordwest
Frankfurt, 60488
OncoResearch Lerchenfeld GmbH
Hamburg
Medizinische Hochschule Hannover
Hanover, 30625
NCT Heidelberg
Heidelberg, 69120
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Universitätsmedizin Mannheim
Mannheim
Klinikum Hochsauerland
Meschede
MVZ Onko Medical GmbH Neustadt
Neustadt am Rübenberge
Clinical Research Stolberg GmbH
Stolberg
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden
About this study
Official title: 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
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).
Read the 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), 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.
Primary objective is to compare the frequency of self-administered parenteral nutrition at home (HPN). Main secondary objectives are to compare the incidence of catheter related infections (CRI), 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.
- Conditions
- Solid Tumor
- Being tested
- Parenteral Nutrition Bag Eurotube, Parenteral Nutrition 2/3 chamber Bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral Nutrition Bag EurotubeDevice
7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.
Parenteral Nutrition 2/3 chamber BagDevice
Premixed 2/3-chamber bags which are eventually completed with other supplements shortly before administration by infusion into the bag.
| Study group | Role | What they receive |
|---|---|---|
| Standard Low Glucose Parenteral Nutrition using Eurotubes® | Patients receive standard PN reduced in glucose in Eurotubes®. Receives: Device: Parenteral Nutrition Bag Eurotube | |
| Standard Parenteral Nutrition using Eurotubes®. | Patients receive standard PN in Eurotubes®. Receives: 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. Receives: Device: Parenteral Nutrition 2/3 chamber Bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 1 year
Secondary outcomes (5)
Relative weight change
Relative weight change determined at baseline and during study visits approx. every four weeks after enrolment
Measured: 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
Measured: up to 1 year
Overall survival
Overall survival (OS) defined as the time from randomization to death from any cause
Measured: 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
Measured: 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".
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start30 Jan 2020
- Primary completion23 Nov 2022
- Study completion31 Jan 2023
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thorsten Goetze, Principal investigator, KHNW Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105777
- Sponsor's protocol ID
- PEKANNUSS
- Other IDs
- AIO-LQ-0119/ass
- Acronym
- PEKANNUSS
- Status last verified
- Jan 2025
- First submitted
- 11 Sep 2019
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
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.
PubMed 40571097
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04105777
- Acronym / sponsor ID
- PEKANNUSS / PEKANNUSS
- Conditions
- Solid Tumor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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), 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.
Primary objective is to compare the frequency of self-administered parenteral nutrition at home (HPN). Main secondary objectives are to compare the incidence of catheter related infections (CRI), 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Low Glucose Parenteral Nutrition using Eurotubes® | – | Device: Parenteral Nutrition Bag EurotubePatients receive standard PN reduced in glucose in Eurotubes®. |
| Standard Parenteral Nutrition using Eurotubes®. | – | Device: Parenteral Nutrition Bag EurotubePatients receive standard PN in Eurotubes®. |
| Standard Parenteral Nutrition using 2/3-chamber bags | – | Device: Parenteral Nutrition 2/3 chamber BagPatients receive PN according to the routine used by the participating site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic or localized solid tumors requiring parenteral nutrition
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral Nutrition Bag Eurotube7-,8- or 9-chamber bags for individualized parenteral nutrition compounding. | Device | Standard Low Glucose Parenteral Nutrition using Eurotubes®, Standard Parenteral Nutrition using Eurotubes®. |
| Parenteral Nutrition 2/3 chamber BagPremixed 2/3-chamber bags which are eventually completed with other supplements shortly before administration by infusion into the bag. | Device | Standard Parenteral Nutrition using 2/3-chamber bags |
Primary outcome
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).
5 secondary outcomes
Relative weight change
Time frame: up to 1 year
Relative change of albumin and CRP
Time frame: up to 1 year
Overall survival
Time frame: up to 4 years
Incidence and severity of adverse events
Time frame: up to 12 months
Patient reported outcomes - Quality of life
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Derived from this study: PubMed 40571097Goetze 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.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Goetze principal investigator
KHNW Frankfurt, Germany
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 15 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients' autonomy (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.