NCT03616431

Pancreatic Cancer Dietary Assessment Study

Prospective Observational Study of Prevalence, Assessment and Treatment of Pancreatic Insufficiency in Patients With Pancreatic Malignancies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective observational study which aims to evaluate; The prevalence of pancreatic insufficiency in patients with pancreatic malignancies (adenocarcinoma and neuroendocrine tumours). The most appropriate diagnostic strategy. The impact that an adequate diagnosis and treatment may have on patients' outcome.

Detailed description

Patients will prospectively receive a full nutritional assessment, pancreatic enzyme insufficiency (PEI) diagnosis and dietician education. This assessment will be performed as an outpatient in parallel with the medical oncology team, by the research dietician. This study will be performed in two steps (summarized in Figure 2); Step-1 \| A prospective cross-sectional assessment of the prevalence of PEI-related symptoms in up to n=150 patients with pancreatic malignancy (this will be termed 'the demographic cohort'). A sub-set of these patients (n=50) will be tested to elucidate the most efficient diagnostic panel for PEI in pancreatic malignancy (this will be termed 'the diagnosis cohort'). Step-2 \| A prospective longitudinal validation of the diagnostic panel designed and tested in Step-1 and evaluation of dietician intervention (including PERT) and its impact in weight loss, symptom evolution, chemotherapy receiving rate, Quality of Life and overall survival (this will be termed 'the follow-up cohort' and will include up to n=50 patients). All patients included in both steps will have a full nutritional assessment at baseline, and PERT treatment (as per standard of care if considered appropriate). Patients in the follow-up cohort will be reviewed (at least every 3 months for a maximum of 6 months since study entry) by dietician for further intervention and assessment.

Conditions

• Pancreatic Neoplasm
• Pancreas Adenocarcinoma
• Well-Differentiated Neuroendocrine Carcinoma
• Malignant Neoplasm of Pancreas

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pancreo-KIT breath test	Pancreo-Kit (Isomed Pharma, Madrid, Spain) is a breath test devised to measure Pancreatic Enzyme Insufficiency. It is a non-invasive method to obtain information about the digestion of consumed lipids; this in turn is informative about the exocrine enzyme activity of the pancreas (specifically pancreatic lipase). This kit is manufactured to EC directive 98/79/EEC and carries the CE mark. The test is based on measurement of 13C which is a stable naturally occurring environmental isotope of carbon with a nucleus containing 6 protons and 7 neutrons (note, it is not radioactive).

Timeline

• Start date: 2018-07-03
• Primary completion: 2020-10-30
• Completion: 2021-05-31
• First posted: 2018-08-06
• Last updated: 2023-08-25

Locations

1 site across 1 country: United Kingdom