Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer
PANUSCO
Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
2 other identifiers
interventional
32
1 country
4
Brief Summary
A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pancreatic-cancer
Started Mar 2010
Typical duration for phase_3 pancreatic-cancer
4 active sites
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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 25, 2014
September 1, 2014
4.4 years
November 25, 2010
September 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Questionnaire EORTC - Quality of Life
The following questionnaires will be given to subjects: * EORTC QLQ-C30 (every 1st and 22nd day of a cycle) * EORTC QLQ Pan-26 (every 1st and 22nd day of a cycle)
every 1st and 22nd day of a cycle
Secondary Outcomes (1)
Assessment of nutritional status
every 1st and 22nd day of a cycle)
Study Arms (2)
Chemotherapy, Nutritional Care
NO INTERVENTION5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43. Subjects in the control group receive Best Supportive Nutritional Care. BSNC is defined as nutritional consultation and recommendation by experienced ecotrophologists.
PN, Chemotherapy, Nutritional Care
EXPERIMENTAL5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43. Patients receive also Best Supportive Nutritional Care defined as nutritional consultation and recommendation by experienced ecotrophologists. Intervention: Supportive Parenteral Nutrition
Interventions
SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.
Eligibility Criteria
You may qualify if:
- Written informed consent
- Histological confirmed advanced pancreatic adenocarcinoma
- At least one previous chemotherapy (gemcitabine-based)
- ≥ 18 years old
- Body weight ≥ 50 and ≤ 95 kg
- BMI ≥ 19
- Negative pregnancy test (females of childbearing potential)
- Willingness to perform double-barrier contraception during study
- Expected life expectancy \> 3 months
You may not qualify if:
- Major surgery \< 4 weeks prior to enrollment
- Weight loss \> 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days
- PINI-Index \> 10
- Pregnancy or breastfeeding
- \> 4 weeks of parenteral nutrition within the last 6 months
- Parenteral nutrition \< 4 weeks prior to enrollment
- Vulnerable populations (e.g. subjects incapable of giving consent personally)
- Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Onkologische Schwerpunktpraxis und Tagesklinik
Bad Soden, 65812, Germany
Krankenhaus Nordwest Frankfurt
Frankfurt am Main, 60488, Germany
University Hospital of Heidelberg / National Center for Tumordiseases
Heidelberg, 69120, Germany
Asklepios Klinik Weißenfels
Weißenfels, 06667, Germany
Related Publications (1)
Marten A, Wente MN, Ose J, Buchler MW, Rotzer I, Decker-Baumann C, Karapanagiotou-Schenkel I, Harig S, Schmidt J, Jager D. An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO. BMC Cancer. 2009 Nov 27;9:412. doi: 10.1186/1471-2407-9-412.
PMID: 19943918BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk Jäger, Prof. Dr.
University of Heidelberg / National Center for Tumordiseases
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2010
First Posted
May 30, 2011
Study Start
March 1, 2010
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
September 25, 2014
Record last verified: 2014-09