PanDA | Pancreatic cancer Dietary Assessment study
Research type
Research Study
Full title
Prospective observational study of prevalence, assessment and treatment of pancreatic insufficiency in patients with pancreatic malignancies.
IRAS ID
194255
Contact name
Juan W Valle
Contact email
Sponsor organisation
The Christie Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
CFTSp109, Christie sponsor reference ; 15_DOG03_309, Christie project ID
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research
The pancreas makes enzymes to digest food into smaller molecules, which the body absorbs. A pancreatic tumour can physically prevent these enzymes leaving the pancreas, which results in dramatic weight loss. Patients with pancreatic cancer need to be reasonably well to have therapy; sudden weight loss can make patients either too unwell to start, or to continue treatment.
Early identification of patients at risk of malnutrition, followed by timely intervention, would avoid or slow the downward spiral in patient health. The best treatment currently for this problem, called pancreatic enzyme insufficiency is Pancreatic Enzyme Replacement Therapy. Currently this is either prescribed too late to be helpful, or given to some patients who would not benefit from it.
We need to be better informed about weight loss and its effect on patients with pancreatic malignancies (both pancreatic cancer and pancreatic neuroendocrine tumours).
To find the best way to identify patients who need dietary intervention, we will use a carefully selected set of blood tests and a commonly used faecal elastase test to see whether this is as good at diagnosing this problem, as a more complex, involved breath-test process.
This study will be run by a research dietician embedded with the clinical team at The Christie Hospital NHS Foundation Trust and was developed through the Pancreatic Subgroup of the National Cancer Research Institute. Funding is from generous donations from Pancreatic Cancer UK and The NET Patient Foundation.
Summary of Results
Between 1st July 2018 and 30th October 2020, 112 eligible patients [50 (DeC), 25 (DiC), 37 (FuC)]. Prevalence of PEI in the DeC was 64.0% (PEI-related symptoms were flatus (84.0%), weight loss (84.0%), abdominal discomfort (50.0%) and steatorrhea (48.0%)); 70.0% of patients required pancreatic enzyme replacement therapy and 74.0% had anorexia (low appetite); 44.0% and 18.0% had low vitamin D and vitamin A levels, respectively. Designed PEI screening panel (DiC; 19 patients with breath test completed) included FE [normal/missing (0 points); low (1 point)] and MUAC [normal/missing ( > percentile 25 for age/gender) (0 points); low (2 points)] and identified patients at high-risk (2-3 total points) of PEI [vs. low-medium risk (0-1 total points)]. When patients from DeC and DiC) were analysed together, those classified as “high-risk of PEI” according to the screening panel had shorter overall survival (multivariable Hazard Ratio (mHR) 1.86 (95% CI 1.03-3.36); p-value 0.040) when adjusted for other prognostic factors, including presence of PEI symptoms (mHR 2.28 (95% CI 1.19-4.35); p-value 0.013). The screening panel was tested in the FuC; 78.38% were classified as patients at “high-risk of PEI”; of these, 89.6% were confirmed to have PEI by the dietitian. The panel was feasible for use in clinical practice, (64.8% of patients completed fully the assessments required) and acceptability was high (87.5% of patients would do it again). The majority of patients (91.3%) recommended that all future patients with aPC should have dietitian input.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
17/NW/0597
Date of REC Opinion
7 Dec 2017
REC opinion
Further Information Favourable Opinion