- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2012-06
2014-02
2014-02
100
NCT02670265
University Medicine Greifswald
University Medicine Greifswald
INTERVENTIONAL
Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-01-28 | N/A | 2016-01-28 |
2016-01-28 | N/A | 2016-02-01 |
2016-02-01 | N/A | 2016-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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% ®
|
| PLACEBO_COMPARATOR: Isotonic fluid Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany) | DIETARY_SUPPLEMENT: Isotonic fluid (E153)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Weight loss | Influence of Olimel Peri 2.%% ® on body weight | ≥ 3 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Nutritional status | Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured. | ≥ 3 days |
| Quality of life | Quality of life was determined using the European EORTC QLQ-C30 form. | ≥ 3 days |
| Length of hospital stay | Length of hospital stay was calculated in days. | ≥ 3 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
