Pancreatic Cancer Dietary Assessment Study (PanDA)

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreas Adenocarcinoma; Pancreatic Neoplasm; Malignant Neoplasm of Pancreas; Well-Differentiated Neuroendocrine Carcinoma
• Intervention / Treatment: Diagnostic test: Pancreo-KIT breath test

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.

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically/cytologically-proven or clinically-suspected (by specialist MDT) pancreatic malignancy including pancreatic ductal adenocarcinoma or pancreatic NET.

Description

Inclusion Criteria:

• Patients with histologically/cytologically-proven or clinically-suspected (by specialist MDT) pancreatic malignancy including pancreatic ductal adenocarcinoma or pancreatic NET.
• Patients to be seen in the Medical Oncology HPB and NET team clinic for assessment
• Age ≥18 years with no upper age limit
• Patients must be able to give informed consent; Written consent will be required for patients to be included within the diagnostic cohort Verbal consent only will be required for patients to be included within the demographic cohort and the follow-up cohort

Additional cohort-specific criteria;

• Patients will be recruited into three different cohorts with differing levels of participation (termed demographic, diagnostic and follow-up). Patients will not be recruited into the follow-up cohort until recruitment of both demographic and diagnosis cohorts are complete and the interim analysis has been performed.
• Demographic cohort | All patients referred for consideration of cancer treatment options will be eligible. Patients will need to give verbal informed consent.
• Diagnosis cohort | Patients who are already consented for being included into the demographic cohort and who will be attending at least to one follow-up appointment and are considered to be fit enough for diagnostic assessment will be eligible. Patients will need to give written informed consent.
• Follow-up cohort | All patients referred for consideration of options of cancer treatment will be included; patients with a minimum of 3 months of follow-up will be included in the final analysis. Patients will need to give verbal informed consent.

Exclusion Criteria:

- As long as the inclusion criteria are fulfilled, there are no exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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 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).
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, quality of life and overall survival.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust
• Collaborators: Pancreatic Cancer UK
• Investigators: Principal Investigator: Juan W Valle, Professor, The Christie NHS Foundation Trust

Publications and helpful links

General Publications

• Carnie LE, Lamarca A, Vaughan K, Kapacee ZA, McCallum L, Backen A, Barriuso J, McNamara MG, Hubner RA, Abraham M, Valle JW. Prospective observational study of prevalence, assessment and treatment of pancreatic exocrine insufficiency in patients with inoperable pancreatic malignancy (PANcreatic cancer Dietary Assessment (PanDA): a study protocol. BMJ Open. 2021 May 13;11(5):e042067. doi: 10.1136/bmjopen-2020-042067.

Helpful Links

• HRA summary of results link

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2018
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pancreatic enzyme replacement therapy; Pancreatic malignancy; Pancreatic enzyme insufficiency; Pancreatic-kit breath test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Neuroendocrine Tumors; Neoplasms; Pancreatic Neoplasms; Carcinoma, Neuroendocrine
• Other Study ID Numbers: 15_DOG03_309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No