Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN)

January 28, 2016 updated by: University Medicine Greifswald

Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Parenteral nutrition
Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany)
Dietary supplement: Olimel Peri 2.5% ®
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.
Placebo Comparator: Isotonic fluid
Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany)
Dietary supplement: Isotonic fluid (E153)
Controls received 1l of isotonic fluid daily by intravenous route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: ≥ 3 days
Influence of Olimel Peri 2.%% ® on body weight
≥ 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: ≥ 3 days
Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured.
≥ 3 days
Quality of life
Time Frame: ≥ 3 days
Quality of life was determined using the European EORTC QLQ-C30 form.
≥ 3 days
Length of hospital stay
Time Frame: ≥ 3 days
Length of hospital stay was calculated in days.
≥ 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Principal Investigator: Markus M Lerch, MD, Department of Medicine A, University Medicine Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB61/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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