Clinical trial NCT04105777: Trial Comparing Parenteral Nutrition (PN) Using Eurotubes® vs. 2/3-chamber Bags in Subjects With Solid Tumors Requiring PN (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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Solid Tumor
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic or localized solid tumors requiring parenteral nutrition

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: patients' autonomy
timeFrame: up to 1 year
Secondary outcomes:
measure: Relative weight change
timeFrame: up to 1 year
measure: Relative change of albumin and CRP
timeFrame: up to 1 year
measure: Overall survival
timeFrame: up to 4 years
measure: Incidence and severity of adverse events
timeFrame: up to 12 months
measure: Patient reported outcomes - Quality of life
timeFrame: up to 12 months
Other outcomes:
measure: Catheter related infections (CRI)
timeFrame: up to 12 months
measure: Catheter related complications
timeFrame: up to 12 months
measure: severe infections
timeFrame: up to 12 months
measure: PN-Related Adverse Events (AEs)
timeFrame: up to 12 months
measure: hospitalizations
timeFrame: up to 12 months
Locations:
city: Berlin
country: Germany
facility: Berlin Spandau Vivantes Klinikum
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel gGmbh, Bielefeld
city: Bochum
country: Germany
facility: Augusta Kranken-Anstalt gGmbH
city: Braunschweig
country: Germany
facility: Praxis Braunschweig
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: NCT Heidelberg
city: Köln
country: Germany
facility: Uniklinikum Köln
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Meschede
country: Germany
facility: Klinikum Hochsauerland
city: Neustadt Am Rübenberge
country: Germany
facility: MVZ Onko Medical GmbH Neustadt
city: Stolberg
country: Germany
facility: Clinical Research Stolberg GmbH
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden
Study officials:
affiliation: KHNW Frankfurt, Germany
name: Thorsten Goetze
role: PRINCIPAL_INVESTIGATOR
References: