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| ID | Type | Description | Link |
|---|---|---|---|
| 60516908 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| Heidelberg University | OTHER |
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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).
Pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion, early metastasis, and marked cachexia. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia and deterioration in performance status, even when their tumour burden is low. Therefore, one of the most important therapeutic targets is the improvement of quality of life. Supplementation with parenteral nutrition improves Quality of Life in subjects with advanced cancer cachexia. The European Society of Parenteral and Enteral Nutrition recommend PN only for malnourished subjects but does not reflect situation in cancer cachexia patients At present, no 2nd-line therapy (or higher) is recommended for pancreatic adenocarcinoma, but often asked for.
Within this clinical trial, we evaluate if parenteral nutrition in combination with chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality of life?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy, Nutritional Care | No Intervention | 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. | |
| PN, Chemotherapy, Nutritional Care | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMOF Kabiven | Drug | SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml. |
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| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire EORTC - Quality of Life | The following questionnaires will be given to subjects:
| every 1st and 22nd day of a cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of nutritional status |
| every 1st and 22nd day of a cycle) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Jäger, Prof. Dr. | University of Heidelberg / National Center for Tumordiseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onkologische Schwerpunktpraxis und Tagesklinik | Bad Soden | 65812 | Germany | |||
| Krankenhaus Nordwest Frankfurt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19943918 | Background | 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Frankfurt am Main |
| 60488 |
| Germany |
| University Hospital of Heidelberg / National Center for Tumordiseases | Heidelberg | 69120 | Germany |
| Asklepios Klinik Weißenfels | Weißenfels | 06667 | Germany |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |