Biliary Tract Cancer, Pancreatic Cancer, Weight Loss
Conditions
Keywords
malnutrition, parenteral nutrition, weight loss, pancreatic cancer, biliary tract cancer, quality of life
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.
Interventions
DIETARY_SUPPLEMENTOlimel 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.
DIETARY_SUPPLEMENTIsotonic fluid (E153)
Controls received 1l of isotonic fluid daily by intravenous route.
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | ≥ 3 days | Influence of Olimel Peri 2.%% ® on body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | ≥ 3 days | Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured. |
| Quality of life | ≥ 3 days | Quality of life was determined using the European EORTC QLQ-C30 form. |
| Length of hospital stay | ≥ 3 days | Length of hospital stay was calculated in days. |
Outcome results
None listed