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

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ClinicalTrials.gov Identifier: NCT04105777
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Brief Summary:
Patients with inoperable metastatic or locally advanced 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).

Condition or disease Intervention/treatment
Solid Tumor Device: Parenteral Nutrition Bag Eurotube Device: Parenteral Nutrition 2/3 chamber Bag

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.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Locally Advanced Inoperable Cancer Requiring Parenteral Nutrition - The PEKANNUSS Trial
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Standard Low Glucose Parenteral Nutrition using Eurotubes®
Patients receive standard PN reduced in glucose in Eurotubes®.
Device: Parenteral Nutrition Bag Eurotube
7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.

Standard Parenteral Nutrition using Eurotubes®.
Patients receive standard PN in Eurotubes®.
Device: Parenteral Nutrition Bag Eurotube
7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.

Standard Parenteral Nutrition using 2/3-chamber bags
Patients receive PN according to the routine used by the participating site.
Device: 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.




Primary Outcome Measures :
  1. catheter related infections [ Time Frame: up to 1 year ]

    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.

    This also includes Catheter-related bloodstream infections (CRBSI), NOS, and Central line-associated bloodstream infections (CLABSI).


  2. 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 50% or more of her/his total administrations (Note: Help of family members or other personal caregivers accounts for self-administration).


Secondary Outcome Measures :
  1. 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

  2. Relative change of albumin and CRP [ Time Frame: up to 1 year ]
    Relative change of albumin and CRP levels measured at baseline and during regular study visits

  3. Overall survival [ Time Frame: up to 4 years ]
    Overall survival (OS) defined as the time from randomization to death from any cause

  4. Incidence and severity of adverse events [ Time Frame: up to 12 months ]
    incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 5.0 criteria as assessed every 4 weeks

  5. 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic or locally advanced inoperable cancer requiring parenteral nutrition
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histologically confirmed metastatic or locally advanced inoperable solid tumor
  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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105777


Contacts
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Contact: Salah-Eddin Al-Batran 00496976014420 albatran@ikf-knnw.de
Contact: Claudia Pauligk 00496976013906 pauligk.claudia@ikf-khnw.de

Locations
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Germany
Institute for Clinical Cancer Research Krankenhaus Nordwest
Frankfurt, Germany, 60488
NCT Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
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Responsible Party: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT04105777    
Other Study ID Numbers: PEKANNUSS
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No