Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer (PANUSCO)

National Center for Tumor Diseases, Heidelberg

Status and phase: Terminated; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: SMOF Kabiven

Study type: Interventional

Funder types: Other

Identifiers

NCT01362582

NCT-2008-11-03-1018

60516908 (Registry Identifier)

Details and patient eligibility

About

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).

Full description

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?

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Chemotherapy, Nutritional Care

No Intervention group

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.

PN, Chemotherapy, Nutritional Care

Experimental group

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

Treatment:

Drug: SMOF Kabiven