Pancreatic Cancer Dietary Assessment Study (PanDA)
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|ClinicalTrials.gov Identifier: NCT03616431|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : September 5, 2019
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.
|Condition or disease||Intervention/treatment|
|Pancreatic Neoplasm Pancreas Adenocarcinoma Well-Differentiated Neuroendocrine Carcinoma Malignant Neoplasm of Pancreas||Diagnostic Test: Pancreo-KIT breath test|
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Prospective Observational Study of Prevalence, Assessment and Treatment of Pancreatic Insufficiency in Patients With Pancreatic Malignancies|
|Actual Study Start Date :||July 3, 2018|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
A prospective cross-sectional assessment of the prevalence of PEI-related symptoms in up to n=150 patients with pancreatic malignancy.
A sub-set (up to n=50) of the Demographic cohort patients will be tested to elucidate the most efficient diagnostic panel for PEI in pancreatic malignancy.
An extra assessment for PEI diagnosis consisting of a breath test (Pancreo-KIT breath test) will be carried out during the following 1-2 weeks after the first appointment (which takes around six hours to complete and involves the administration of bread spread with 13C butter followed by collection of the patient's breath in small plastic vials at timed intervals. The vials will subsequently be analyzed for 13C quantity; details in Appendix 6). Following these diagnostic tests, patients will complete an "acceptability questionnaire" to assess their opinion regarding the burden that these diagnostic tests may add.
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).
Validation of the diagnostic panel designed and tested in Step-1 of this study and evaluation of dietician intervention (including Pancreatic Enzyme Replacement Therapy; PERT) and its impact in weight loss, symptom evolution, chemotherapy receiving rate, quality of life and overall survival.
- Determine prevalence of pancreatic enzyme insufficiency in patients with pancreatic neoplasms. [ Time Frame: 2 years ]Prevalence will be given as a percentage of all patients with pancreatic neoplasms with evidence of pancreatic enzyme insufficiency
- To determine the prevalence of PEI-related symptoms at first oncological referral. [ Time Frame: 1 year ]Percentage of patients with documented biochemical evidence of pancreatic enzyme insufficiency with related symptoms
- To evaluate nutritional status of patients at the time of oncological referral (using a panel of 'standard of care' blood tests parameters). [ Time Frame: 1 year ]Using defined dietetic endpoints
- To assess the feasibility of performing the PEI breath test and the fecal elastase-1 measurement. [ Time Frame: 1 year ]Described as a percentage of successful tests completed by patients
- To assess, using the "acceptability questionnaire" (developed specifically for this study), the acceptability of these investigations by patients. [ Time Frame: 1 year ]To quantify acceptability on a pre-defined score for each of the tests.
- To identify, through semi structured interviews and thematic analysis, diet-related themes of interest in a subset of patients involved in this study [ Time Frame: 1 year ]Themes will be described in a semi-quantitative report arising from the interviews.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616431
|The Christie NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom, M20 4BX|
|Contact: Juan Valle, MD +44 161 446 3468 firstname.lastname@example.org|
|Principal Investigator:||Juan W Valle, Professor||The Christie NHS Foundation Trust|