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Parenteral Nutrition Support for Patients With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00919659
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : June 12, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : January 2004
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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:
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
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
Cachexia
Wasting Syndrome
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
Metabolic Diseases
Nutrition Disorders