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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

Detailed 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?

Interventions

  • Drug: SMOF Kabiven
    • SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.

Arms, Groups and Cohorts

  • No Intervention: Chemotherapy, Nutritional Care
    • 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
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Questionnaire EORTC – Quality of Life
    • Time Frame: every 1st and 22nd day of a cycle
    • 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)

Secondary Measures

  • Assessment of nutritional status
    • Time Frame: every 1st and 22nd day of a cycle)
    • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Center for Tumor Diseases, Heidelberg
  • Collaborator
    • Heidelberg University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dirk Jäger, Prof. Dr., Principal Investigator, University of Heidelberg / National Center for Tumordiseases

References

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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