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Treatment of pancreatic insufficiency using pancreatic extract in patients with advanced pancreatic cancer: a pilot study (PICNIC)

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Abstract

Purpose

Survival with advanced pancreatic cancer is less than 12 months. Pancreatic exocrine insufficiency may contribute to pancreatic cancer-related cachexia, via nutrient malabsorption. We aimed to determine the feasibility of prescribing pancreatic extract (Creon®) for patients with advanced pancreatic cancer.

Methods

Patients with advanced pancreatic cancer, without frank malabsorption, were randomised in this feasibility study to pancreatic extract 50,000 units with meals and 25,000 units with snacks, or placebo. Standardised dietary advice was given. Anti-cancer and supportive care treatments were permitted. Outcomes included weight, body mass index (BMI), quality of life (QLQC30, PAN26), survival and nutritional assessment (PG-SGA).

Results

Eighteen patients were randomised before study closure due to slow recruitment. Baseline characteristics were well matched. Weight loss prior to randomisation was numerically greater in the pancreatic extract group (mean 0.7 vs 2.2 kg). Weight loss was numerically greater in the placebo group, however not significantly. No differences in BMI or nutrition score were seen. Quality of life did not differ between study groups. Median overall survival was 17 (95% CI 8.1–48.7) weeks in the control group, and 67.6 (95% CI 14.1–98.4) weeks in the pancreatic extract group (p = 0.1063). Only 17% (18/106) of potentially eligible patients were recruited, related to patient/family reluctance, rapid clinical deterioration and patients already prescribed pancreatic extract. A moderate pill burden was noted.

Conclusion

Despite intriguing survival results, this study was not sufficiently feasible to proceed to a fully powered comparative study. A multi-centre study would be required to exclude a significant difference in outcomes.

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Acknowledgements

We would like to thank study participants and their families, and site study staff for their contribution to this study.

Author contributions

Conception and design: NZ, GR, AB, AF

Participant recruitment: NZ, AB

Data collection: NZ, AB, LP, JC

Data analysis: CO, NZ.

Manuscript preparation and critical review: All authors

Review of final manuscript: All authors

All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

The corresponding author has access to the full dataset and agrees that the journal may inspect that data if required.

Author information

Correspondence to Nicholas Zdenkowski.

Ethics declarations

This study was designed in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation–Good Clinical Practice guidelines. It was prospectively approved by the Hunter New England Local Health District Human Research Ethics Committee (approval number 11/07/20/3.01), and registered on the Australian and New Zealand Clinical Trial Registry (www.anzctr.org.au, ACTRN12612000299808). All participants provided voluntary informed consent prior to any study-related procedures. The study drug manufacturer was not involved in the design, funding, conduct or analysis of this study.

Conflict of interest

The authors declare that they have no conflict of interest.

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Zdenkowski, N., Radvan, G., Pugliese, L. et al. Treatment of pancreatic insufficiency using pancreatic extract in patients with advanced pancreatic cancer: a pilot study (PICNIC). Support Care Cancer 25, 1963–1971 (2017). https://doi.org/10.1007/s00520-017-3602-2

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Keywords

  • Pancreatic insufficiency
  • Cachexia
  • Malabsorption
  • Pancreatic cancer