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
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
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
NCT ID
NCT02670265
First Posted
January 28, 2016
Last Updated
January 28, 2016
Sponsor
University Medicine Greifswald
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
Learn more about this trial
Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions
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