NCT00919659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

2 years

First QC Date

June 9, 2009

Last Update Submit

June 11, 2009

Conditions

Cancer CachexiaPancreatic Cancer

Keywords

parenteral nutritioncancer cachexiapancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • nutritional status presented by phase angle

    12 weeks

Secondary Outcomes (1)

  • quantity of port infections, quantity of oedema, quantity of diarrhea

    12 weeks

Study Arms (1)

parenteral nutrition

EXPERIMENTAL

25kcal/kg/bw /day via parenteral support

Dietary Supplement: parenteral nutrition

Interventions

parenteral nutritionDIETARY_SUPPLEMENT

25kcal/kg bw with parenteral nutrition

Also known as: no specific brand name
parenteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • prefinal status
  • septic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin Berlin - Charité

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

  • Pelzer U, Arnold D, Govercin M, Stieler J, Doerken B, Riess H, Oettle H. Parenteral nutrition support for patients with pancreatic cancer. Results of a phase II study. BMC Cancer. 2010 Mar 9;10:86. doi: 10.1186/1471-2407-10-86.

    PMID: 20214798DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsHyperphagia

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • helmut oettle, MD

    CONKO-Studiengruppe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 12, 2009

Study Start

January 1, 2002

Primary Completion

January 1, 2004

Study Completion

May 1, 2004

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

DE(1)