Parenteral Nutrition Support for Patients With Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00919659
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : June 12, 2009
Fresenius AG
Information provided by:

Brief Summary:
The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.

Condition or disease Intervention/treatment Phase
Cancer Cachexia Pancreatic Cancer Dietary Supplement: parenteral nutrition Phase 2

Detailed Description:
To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.
Study Start Date : January 2002
Actual Primary Completion Date : January 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: parenteral nutrition
25kcal/kg/bw /day via parenteral support
Dietary Supplement: parenteral nutrition
25kcal/kg bw with parenteral nutrition
Other Name: no specific brand name

Primary Outcome Measures :
  1. nutritional status presented by phase angle [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. quantity of port infections, quantity of oedema, quantity of diarrhea [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histological proved pancreatic cancer
  • progressive cancer cachexia
  • refractive to enteral supplementation
  • informed consent

Exclusion Criteria:

  • prefinal status
  • septic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00919659

Universitätsmedizin Berlin - Charité
Berlin, Germany, 13353
Sponsors and Collaborators
Fresenius AG
Principal Investigator: helmut oettle, MD CONKO-Studiengruppe

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Helmut Oettle MD, Universitätsmedizin Berlin - Charité Identifier: NCT00919659     History of Changes
Other Study ID Numbers: C25.0
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by CONKO-Studiengruppe:
parenteral nutrition
cancer cachexia
pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Wasting Syndrome
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders