Pancreatic Cancer Dietary Assessment Study

NCT03616431 | Completed DMC

• 1 other identifier: 15_DOG03_309
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Neoplasm; Pancreas Adenocarcinoma; Well-Differentiated Neuroendocrine Carcinoma; Malignant Neoplasm of Pancreas

Keywords

Pancreatic malignancy; Pancreatic enzyme insufficiency; Pancreatic enzyme replacement therapy; Pancreatic-kit breath test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To determine the prevalence of PEI-related symptoms at first oncological referral.

  1 year

• To evaluate nutritional status of patients at the time of oncological referral (using a panel of 'standard of care' blood tests parameters).

  1 year

• To assess the feasibility of performing the PEI breath test and the fecal elastase-1 measurement.

  1 year

• To assess, using the "acceptability questionnaire" (developed specifically for this study), the acceptability of these investigations by patients.

  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

  1 year

Study Arms (3)

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

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.

Interventions

Pancreo-KIT breath test DIAGNOSTIC_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).

Diagnosis cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• Pancreatic Cancer UK: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33986039 BACKGROUND

Related Links

• HRA summary of results link

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Juan W Valle, Professor

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: August 6, 2018
• Study Start: July 3, 2018
• Primary Completion: October 30, 2020
• Study Completion: May 31, 2021
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

GB (1)