Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions

Pancreatic Cancer Clinical Trial

— NUPAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670265
• Other study ID #: BB61/12
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: January 28, 2016
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Weight Loss

Intervention

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.
• Isotonic fluid (E153)
Controls received 1l of isotonic fluid daily by intravenous route.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Influence of Olimel Peri 2.%% ® on body weight	= 3 days	No
Secondary	Nutritional status	Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured.	= 3 days	No
Secondary	Quality of life	Quality of life was determined using the European EORTC QLQ-C30 form.	= 3 days	No
Secondary	Length of hospital stay	Length of hospital stay was calculated in days.	= 3 days	No