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

Solid Tumor Clinical Trial

— PEKANNUSS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04105777
• Other study ID #: PEKANNUSS
• Secondary ID: AIO-LQ-0119/ass
• Status: Terminated
• Start date: January 30, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: July 2023
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: January 31, 2023
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Device:
• Parenteral Nutrition Bag Eurotube
7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.
• Parenteral Nutrition 2/3 chamber Bag
Premixed 2/3-chamber bags which are eventually completed with other supplements shortly before administration by infusion into the bag.

Locations

Country	Name	City	State
Germany	Berlin Spandau Vivantes Klinikum	Berlin
Germany	Evangelisches Klinikum Bethel gGmbh, Bielefeld	Bielefeld
Germany	Augusta Kranken-Anstalt gGmbH	Bochum
Germany	Praxis Braunschweig	Braunschweig
Germany	Krankenhaus Nordwest	Frankfurt
Germany	OncoResearch Lerchenfeld GmbH	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	NCT Heidelberg	Heidelberg
Germany	Uniklinikum Köln	Köln
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	Klinikum Hochsauerland	Meschede
Germany	MVZ Onko Medical GmbH Neustadt	Neustadt Am Rübenberge
Germany	Clinical Research Stolberg GmbH	Stolberg
Germany	Helios Dr. Horst Schmidt Kliniken Wiesbaden	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Catheter related infections (CRI)	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	up to 12 months
Other	Catheter related complications	Catheter related complications such as line occlusions of catheter-related central venous thrombosis	up to 12 months
Other	severe infections	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	up to 12 months
Other	PN-Related Adverse Events (AEs)	PN-Related Adverse Events (AEs) during therapy	up to 12 months
Other	hospitalizations	hospitalizations during therapy	up to 12 months
Primary	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	Relative weight change	Relative weight change determined at baseline and during study visits approx. every four weeks after enrolment	up to 1 year
Secondary	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
Secondary	Overall survival	Overall survival (OS) defined as the time from randomization to death from any cause	up to 4 years
Secondary	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
Secondary	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