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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
Sponsor:
Collaborator:
Pancreatic Cancer UK
Information provided by (Responsible Party):
Juan Valle, The Christie NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Pancreatic Neoplasm Pancreas Adenocarcinoma Well-Differentiated Neuroendocrine Carcinoma Malignant Neoplasm of Pancreas 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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.


Information from the National Library of Medicine

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


Locations
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United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Juan Valle, MD    +44 161 446 3468    juan.valle@christie.nhs.uk   
Sponsors and Collaborators
The Christie NHS Foundation Trust
Pancreatic Cancer UK
Investigators
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Principal Investigator: Juan W Valle, Professor The Christie NHS Foundation Trust

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Responsible Party: Juan Valle, Professor, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03616431     History of Changes
Other Study ID Numbers: 15_DOG03_309
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Valle, The Christie NHS Foundation Trust:
Pancreatic malignancy
Pancreatic enzyme insufficiency
Pancreatic enzyme replacement therapy
Pancreo-kit breath test
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma, Neuroendocrine
Carcinoma
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases