Clinical trial · Interventional
Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer
Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
NCT01362582CI-TRIAL-00015701PANUSCOterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SMOF Kabiven | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Chemotherapy, Nutritional Care
- description
- 5-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.
- type
- EXPERIMENTAL
- label
- PN, Chemotherapy, Nutritional Care
- description
- 5-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
- interventionNames
- Drug: SMOF Kabiven
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- BACKGROUNDMarten 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 19943918