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2018-07-03
2020-10-30
2021-05-31
112
NCT03616431
The Christie NHS Foundation Trust
The Christie NHS Foundation Trust
OBSERVATIONAL
Pancreatic Cancer Dietary Assessment Study
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-05-08 | N/A | 2023-08-23 |
2018-08-03 | N/A | 2023-08-25 |
2018-08-06 | N/A | 2023-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Demographic cohort A prospective cross-sectional assessment of the prevalence of PEI-related symptoms in up to n=150 patients with pancreatic malignancy. | |
| : Diagnosis cohort 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 b | DIAGNOSTIC_TEST: Pancreo-KIT breath test
|
| : Follow-up cohort 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, |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Determine prevalence of pancreatic enzyme insufficiency in patients with pancreatic neoplasms. | Prevalence will be given as a percentage of all patients with pancreatic neoplasms with evidence of pancreatic enzyme insufficiency | 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| To determine the prevalence of PEI-related symptoms at first oncological referral. | Percentage of patients with documented biochemical evidence of pancreatic enzyme insufficiency with related symptoms | 1 year |
| To evaluate nutritional status of patients at the time of oncological referral (using a panel of 'standard of care' blood tests parameters). | Using defined dietetic endpoints | 1 year |
| To assess the feasibility of performing the PEI breath test and the fecal elastase-1 measurement. | Described as a percentage of successful tests completed by patients | 1 year |
| To assess, using the "acceptability questionnaire" (developed specifically for this study), the acceptability of these investigations by patients. | To quantify acceptability on a pre-defined score for each of the tests. | 1 year |
| To identify, through semi structured interviews and thematic analysis, diet-related themes of interest in a subset of patients involved in this study | Themes will be described in a semi-quantitative report arising from the interviews. | 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
