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

Study Overview
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Brief Summary
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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).

Detailed Description
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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?

Official Title
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Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: SMOF Kabiven


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Chemotherapy, Nutritional Care<br>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. | |
| Experimental: PN, Chemotherapy, Nutritional Care<br>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 | Drug: SMOF Kabiven<br>* SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of nutritional status | BIA: Phase angle, BCM and Extracellular Mass (ECM)/BCM ratio (every 1st and 22nd day of a cycle) BMI (every 1st and 22nd day of a cycle) Biceps size(every 1st and 22nd day of a cycle) Hand-grip-strength(every 1st and 22nd day of a cycle) PINI-Index (every 1st and 22nd day of a cycle) | every 1st and 22nd day of a cycle) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, progression under chemotherapy, parenteral nutrition, pancreatic adenocarcinoma, chemotherapy