Pancreatic Cancer Dietary Assessment Study — PanDA  

Pancreatic Neoplasm Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03616431
• Study type: Observational
• Source: The Christie NHS Foundation Trust
• Status: Completed
• Start date: July 3, 2018
• Completion date: May 31, 2021