Parenteral Nutrition Support for Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Fresenius AG
Information provided by:
CONKO-Studiengruppe
ClinicalTrials.gov Identifier:
NCT00919659
First received: June 9, 2009
Last updated: June 11, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Cancer Cachexia
Pancreatic Cancer
Dietary Supplement: parenteral nutrition
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.

Resource links provided by NLM:


Further study details as provided by CONKO-Studiengruppe:

Primary Outcome Measures:
  • nutritional status presented by phase angle [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quantity of port infections, quantity of oedema, quantity of diarrhea [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: January 2002
Study Completion Date: May 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • prefinal status
  • septic disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919659

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

Additional Information:
No publications provided by CONKO-Studiengruppe

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helmut Oettle MD, Universitätsmedizin Berlin - Charité
ClinicalTrials.gov Identifier: NCT00919659     History of Changes
Other Study ID Numbers: C25.0
Study First Received: June 9, 2009
Last Updated: June 11, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cachexia
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014