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Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN)

Primary Purpose

Weight Loss, Pancreatic Cancer, Biliary Tract Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Olimel Peri 2.5% ®
Isotonic fluid (E153)
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight Loss focused on measuring malnutrition, parenteral nutrition, weight loss, pancreatic cancer, biliary tract cancer, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalization for suspected biliopancreatic mass lesion
  • Consent to participate to the study

Exclusion Criteria:

  • Liver cirrhosis (Child-Pugh B and C)
  • Heart or renal failure (grade III or more)
  • Dementia
  • Pregnancy
  • Hospital stay less than 3 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Parenteral nutrition

    Isotonic fluid

    Arm Description

    Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany)

    Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany)

    Outcomes

    Primary Outcome Measures

    Weight loss
    Influence of Olimel Peri 2.%% ® on body weight

    Secondary Outcome Measures

    Nutritional status
    Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured.
    Quality of life
    Quality of life was determined using the European EORTC QLQ-C30 form.
    Length of hospital stay
    Length of hospital stay was calculated in days.

    Full Information

    First Posted
    January 28, 2016
    Last Updated
    January 28, 2016
    Sponsor
    University Medicine Greifswald
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02670265
    Brief Title
    Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions
    Acronym
    NUPAN
    Official Title
    Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Medicine Greifswald

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many procedures for diagnostic workup that require fasting periods. In a prospective randomized monocentric study we evaluate the effect of additional parenteral nutrition on weight loss, nutritional status, quality of life and length of hospital stay.
    Detailed Description
    Patients with pancreatic and biliary tract cancer suffer from weight loss, malnutrition and cachexia. These factors are associated with poor prognosis, reduction in quality of life and a higher risk of complications during treatment. Moreover, patients undergo fasting periods during their diagnostic work-up at hospital that worsens malnutrition. This is a prospective randomized monocentric study to investigate, whether parenteral nutritional supplementation may have an impact on weight loss, nutritional status, quality of life and length of hospital stay in patients with tumors of the pancreas or biliary tract. Patients either receive 1 l Olimel peri 2.5 %® (Baxter Germany GmbH Medication Delivery, Unterschleißheim, Germany containing 700 kcal, 25.3 g protein, 30.0 g fat and 75.0 g glucose) on fasting days or 1 l of isotonic fluid (E153, Berlin-Chemie AG, Berlin, Germany) in the control group. A hospital stay of at least three days is required. Patients are assessed for anthropometric measurements, bioelectrical impedance analysis, quality of life and length of hospital stay.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss, Pancreatic Cancer, Biliary Tract Cancer
    Keywords
    malnutrition, parenteral nutrition, weight loss, pancreatic cancer, biliary tract cancer, quality of life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Parenteral nutrition
    Arm Type
    Active Comparator
    Arm Description
    Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany)
    Arm Title
    Isotonic fluid
    Arm Type
    Placebo Comparator
    Arm Description
    Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Olimel Peri 2.5% ®
    Intervention Description
    During hospital stay patients received 1 l Olimel peri 2.5 %® containing 700 kcal (25.3 g protein, 30.0 g fat and 75.0 g glucose) daily by intravenous route.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Isotonic fluid (E153)
    Intervention Description
    Controls received 1l of isotonic fluid daily by intravenous route.
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    Influence of Olimel Peri 2.%% ® on body weight
    Time Frame
    ≥ 3 days
    Secondary Outcome Measure Information:
    Title
    Nutritional status
    Description
    Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured.
    Time Frame
    ≥ 3 days
    Title
    Quality of life
    Description
    Quality of life was determined using the European EORTC QLQ-C30 form.
    Time Frame
    ≥ 3 days
    Title
    Length of hospital stay
    Description
    Length of hospital stay was calculated in days.
    Time Frame
    ≥ 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitalization for suspected biliopancreatic mass lesion Consent to participate to the study Exclusion Criteria: Liver cirrhosis (Child-Pugh B and C) Heart or renal failure (grade III or more) Dementia Pregnancy Hospital stay less than 3 days
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Markus M Lerch, MD
    Organizational Affiliation
    Department of Medicine A, University Medicine Greifswald
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27861546
    Citation
    Kruger J, Meffert PJ, Vogt LJ, Gartner S, Steveling A, Kraft M, Mayerle J, Lerch MM, Aghdassi AA. Early Parenteral Nutrition in Patients with Biliopancreatic Mass Lesions, a Prospective, Randomized Intervention Trial. PLoS One. 2016 Nov 18;11(11):e0166513. doi: 10.1371/journal.pone.0166513. eCollection 2016.
    Results Reference
    derived

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    Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions

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