<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02985801</url>
  </required_header>
  <id_info>
    <org_study_id>15-008713</org_study_id>
    <nct_id>NCT02985801</nct_id>
  </id_info>
  <brief_title>PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer</brief_title>
  <official_title>Pancreatic Enzyme Replacement Therapy (PERT) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massimo Raimondo, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Digestive Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in&#xD;
      patients with unresectable pancreatic cancer?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme&#xD;
      replacement therapy in weight loss and quality of life.&#xD;
&#xD;
      Prevalence of pancreatic exocrine insufficiency (PEI) will be determined with fecal&#xD;
      elastase-1 test (FE1) in patients with unresectable pancreatic cancer, without evidence of&#xD;
      pancreatic duct (PD) or common bile duct (CBD) obstruction based on MRI or / and endoscopic&#xD;
      ultrasound (EUS).&#xD;
&#xD;
      Patients with PEI (FE1 &lt;200) receive Pertzye or placebo in a cross-over fashion, each for 4&#xD;
      weeks.&#xD;
&#xD;
      Body weight, body mass index (BMI), body composition (Bioimpedance), are measured at the time&#xD;
      of diagnosis of PEI and at 4 and 10 weeks of cross-over treatment. Baseline measurement of&#xD;
      Vitamin D-25, Vitamin A, iron (ferritin, total iron binding capacity (TIBC), iron), Vitamin&#xD;
      B12,Tissue transglutaminase IgA (tTG) with total Immunoglobulin A (IgA).&#xD;
&#xD;
      Quality of Life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the&#xD;
      Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas&#xD;
      cancer (FACT-Hep) for physical, social, emotional, and functional quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated due to difficulty in recruiting subjects.&#xD;
  </why_stopped>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Baseline, 4 weeks, 10 weeks</time_frame>
    <description>Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks</measure>
    <time_frame>Baseline, 10 weeks</time_frame>
    <description>Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight Composition</measure>
    <time_frame>Baseline, 4 weeks, 10 weeks</time_frame>
    <description>Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Pancreatic Insufficiency</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Pancreatic Enzyme Abnormality</condition>
  <arm_group>
    <arm_group_label>Placebo First, then Pancrelipase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pancrelipase First, then Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pancrelipase</intervention_name>
    <description>Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units</description>
    <arm_group_label>Pancrelipase First, then Placebo</arm_group_label>
    <arm_group_label>Placebo First, then Pancrelipase</arm_group_label>
    <other_name>Pertzye</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>Placebo Oral Capsule</description>
    <arm_group_label>Pancrelipase First, then Placebo</arm_group_label>
    <arm_group_label>Placebo First, then Pancrelipase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18-80 years&#xD;
&#xD;
          -  Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant&#xD;
             metastasis)&#xD;
&#xD;
          -  On established chemotherapy regimen for pancreas cancer, which will be continued over&#xD;
             the time of study&#xD;
&#xD;
          -  Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Common bile duct obstruction resulting in obstructive jaundice&#xD;
&#xD;
          -  Celiac disease&#xD;
&#xD;
          -  Crohn's disease&#xD;
&#xD;
          -  Benign pancreatic conditions&#xD;
&#xD;
          -  Bowel obstruction&#xD;
&#xD;
          -  Surgically altered bowel anatomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimo Raimondo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <reference>
    <citation>Heffernan N, Cella D, Webster K, Odom L, Martone M, Passik S, Bookbinder M, Fong Y, Jarnagin W, Blumgart L. Measuring health-related quality of life in patients with hepatobiliary cancers: the functional assessment of cancer therapy-hepatobiliary questionnaire. J Clin Oncol. 2002 May 1;20(9):2229-39. doi: 10.1200/JCO.2002.07.093.</citation>
    <PMID>11980994</PMID>
  </reference>
  <reference>
    <citation>Perez MM, Newcomer AD, Moertel CG, Go VL, Dimagno EP. Assessment of weight loss, food intake, fat metabolism, malabsorption, and treatment of pancreatic insufficiency in pancreatic cancer. Cancer. 1983 Jul 15;52(2):346-52. doi: 10.1002/1097-0142(19830715)52:23.0.co;2-z.</citation>
    <PMID>6305473</PMID>
  </reference>
  <reference>
    <citation>Partelli S, Frulloni L, Minniti C, Bassi C, Barugola G, D'Onofrio M, Crippa S, Falconi M. Faecal elastase-1 is an independent predictor of survival in advanced pancreatic cancer. Dig Liver Dis. 2012 Nov;44(11):945-51. doi: 10.1016/j.dld.2012.05.017. Epub 2012 Jun 28.</citation>
    <PMID>22749648</PMID>
  </reference>
  <reference>
    <citation>Sikkens EC, Cahen DL, de Wit J, Looman CW, van Eijck C, Bruno MJ. A prospective assessment of the natural course of the exocrine pancreatic function in patients with a pancreatic head tumor. J Clin Gastroenterol. 2014 May-Jun;48(5):e43-6. doi: 10.1097/MCG.0b013e31829f56e7.</citation>
    <PMID>24717227</PMID>
  </reference>
  <reference>
    <citation>Dutta SK, Rubin J, Harvey J. Comparative evaluation of the therapeutic efficacy of a pH-sensitive enteric coated pancreatic enzyme preparation with conventional pancreatic enzyme therapy in the treatment of exocrine pancreatic insufficiency. Gastroenterology. 1983 Mar;84(3):476-82.</citation>
    <PMID>6549746</PMID>
  </reference>
  <reference>
    <citation>Valerio D, Whyte EH, Schlamm HT, Ruggiero JA, Blackburn GL. Clinical effectiveness of a pancreatic enzyme supplement. JPEN J Parenter Enteral Nutr. 1981 Mar-Apr;5(2):110-4. doi: 10.1177/0148607181005002110.</citation>
    <PMID>7195437</PMID>
  </reference>
  <reference>
    <citation>Bruno MJ, Haverkort EB, Tijssen GP, Tytgat GN, van Leeuwen DJ. Placebo controlled trial of enteric coated pancreatin microsphere treatment in patients with unresectable cancer of the pancreatic head region. Gut. 1998 Jan;42(1):92-6. doi: 10.1136/gut.42.1.92.</citation>
    <PMID>9505892</PMID>
  </reference>
  <reference>
    <citation>Delchier JC, Vidon N, Saint-Marc Girardin MF, Soule JC, Moulin C, Huchet B, Zylberberg P. Fate of orally ingested enzymes in pancreatic insufficiency: comparison of two pancreatic enzyme preparations. Aliment Pharmacol Ther. 1991 Aug;5(4):365-78. doi: 10.1111/j.1365-2036.1991.tb00040.x.</citation>
    <PMID>1777547</PMID>
  </reference>
  <reference>
    <citation>Ghaneh P, Neoptolemos JP. Exocrine pancreatic function following pancreatectomy. Ann N Y Acad Sci. 1999 Jun 30;880:308-18. doi: 10.1111/j.1749-6632.1999.tb09534.x.</citation>
    <PMID>10415875</PMID>
  </reference>
  <reference>
    <citation>DiMagno EP, Malagelada JR, Go VL. The relationships between pancreatic ductal obstruction and pancreatic secretion in man. Mayo Clin Proc. 1979 Mar;54(3):157-62.</citation>
    <PMID>431121</PMID>
  </reference>
  <reference>
    <citation>Graham DY. An enteric-coated pancreatic enzyme preparation that works. Dig Dis Sci. 1979 Dec;24(12):906-9. doi: 10.1007/BF01311943.</citation>
    <PMID>510089</PMID>
  </reference>
  <reference>
    <citation>Halgreen H, Pedersen NT, Worning H. Symptomatic effect of pancreatic enzyme therapy in patients with chronic pancreatitis. Scand J Gastroenterol. 1986 Jan;21(1):104-8. doi: 10.3109/00365528609034631.</citation>
    <PMID>3633631</PMID>
  </reference>
  <reference>
    <citation>Lankisch PG, Lembcke B, Goke B, Creutzfeldt W. Therapy of pancreatogenic steatorrhoea: does acid protection of pancreatic enzymes offer any advantage? Z Gastroenterol. 1986 Dec;24(12):753-7.</citation>
    <PMID>3548109</PMID>
  </reference>
  <reference>
    <citation>Schneider MU, Knoll-Ruzicka ML, Domschke S, Heptner G, Domschke W. Pancreatic enzyme replacement therapy: comparative effects of conventional and enteric-coated microspheric pancreatin and acid-stable fungal enzyme preparations on steatorrhoea in chronic pancreatitis. Hepatogastroenterology. 1985 Apr;32(2):97-102.</citation>
    <PMID>2408983</PMID>
  </reference>
  <reference>
    <citation>Nouisa-Arvanitakis S, Stapleton FB, Linshaw MA, Kennedy J. Therapeutic approach to pancreatic extract-induced hyperuricosuria in cystic fibrosis. J Pediatr. 1977 Feb;90(2):302-5. doi: 10.1016/s0022-3476(77)80657-4.</citation>
    <PMID>830926</PMID>
  </reference>
  <reference>
    <citation>Gullo L, Pezzilli R, Gaiani S. Tolerability and safety of the long-term administration of pancreatic extracts. Pancreas. 1997 Mar;14(2):210-2. doi: 10.1097/00006676-199703000-00018. No abstract available.</citation>
    <PMID>9057197</PMID>
  </reference>
  <reference>
    <citation>Seiler CM, Izbicki J, Varga-Szabo L, Czako L, Fiok J, Sperti C, Lerch MM, Pezzilli R, Vasileva G, Pap A, Varga M, Friess H. Randomised clinical trial: a 1-week, double-blind, placebo-controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1-year open-label extension. Aliment Pharmacol Ther. 2013 Apr;37(7):691-702. doi: 10.1111/apt.12236. Epub 2013 Feb 5.</citation>
    <PMID>23383603</PMID>
  </reference>
  <reference>
    <citation>Ramesh H, Reddy N, Bhatia S, Rajkumar JS, Bapaye A, Kini D, Kalla M, Thorat V. A 51-week, open-label clinical trial in India to assess the efficacy and safety of pancreatin 40000 enteric-coated minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis. Pancreatology. 2013 Mar-Apr;13(2):133-9. doi: 10.1016/j.pan.2013.01.009. Epub 2013 Feb 5.</citation>
    <PMID>23561971</PMID>
  </reference>
  <reference>
    <citation>Gubergrits N, Malecka-Panas E, Lehman GA, Vasileva G, Shen Y, Sander-Struckmeier S, Caras S, Whitcomb DC. A 6-month, open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery. Aliment Pharmacol Ther. 2011 May;33(10):1152-61. doi: 10.1111/j.1365-2036.2011.04631.x. Epub 2011 Mar 21.</citation>
    <PMID>21418260</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>February 3, 2021</results_first_submitted>
  <results_first_submitted_qc>February 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2021</results_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Massimo Raimondo, M.D.</investigator_full_name>
    <investigator_title>Professor, College of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Exocrine Pancreatic Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
    <mesh_term>Pancreatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02985801/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo First, Then Pancrelipase</title>
          <description>Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).&#xD;
Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="P2">
          <title>Pancrelipase First, Then Placebo</title>
          <description>Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).&#xD;
Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo First, Then Pancrelipase</title>
          <description>Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).&#xD;
Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="B2">
          <title>Pancrelipase First, Then Placebo</title>
          <description>Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).&#xD;
Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.1" spread="7.6"/>
                    <measurement group_id="B2" value="68.3" spread="6.9"/>
                    <measurement group_id="B3" value="65.2" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Body Weight</title>
        <description>Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.</description>
        <time_frame>Baseline, 4 weeks, 10 weeks</time_frame>
        <population>Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Subjects who received placebo oral capsule in either the first or last 4 weeks of the study</description>
          </group>
          <group group_id="O2">
            <title>Pancrelipase</title>
            <description>Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight</title>
          <description>Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.</description>
          <population>Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks</title>
        <description>Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <population>Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Subjects who received placebo oral capsule in either the first or last 4 weeks of the study</description>
          </group>
          <group group_id="O2">
            <title>Pancrelipase</title>
            <description>Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks</title>
          <description>Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).</description>
          <population>Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks</title>
        <description>Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).</description>
        <time_frame>Baseline, 10 weeks</time_frame>
        <population>Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Subjects who received placebo oral capsule in either the first or last 4 weeks of the study</description>
          </group>
          <group group_id="O2">
            <title>Pancrelipase</title>
            <description>Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks</title>
          <description>Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).</description>
          <population>Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight Composition</title>
        <description>Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.</description>
        <time_frame>Baseline, 4 weeks, 10 weeks</time_frame>
        <population>Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Subjects who received placebo oral capsule in either the first or last 4 weeks of the study</description>
          </group>
          <group group_id="O2">
            <title>Pancrelipase</title>
            <description>Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight Composition</title>
          <description>Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.</description>
          <population>Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline to end of study for a total of approximately 10 weeks on all participants.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Subjects who received placebo oral capsule in either the first or last 4 weeks of the study</description>
        </group>
        <group group_id="E2">
          <title>Pancrelipase</title>
          <description>Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Massimo Raimondo</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>904-953-6982</phone>
      <email>Raimondo.Massimo@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02985801
org study id: 15-008713
nct id: NCT02985801
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in
      patients with unresectable pancreatic cancer?
Randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme
      replacement therapy in weight loss and quality of life.

      Prevalence of pancreatic exocrine insufficiency (PEI) will be determined with fecal
      elastase-1 test (FE1) in patients with unresectable pancreatic cancer, without evidence of
      pancreatic duct (PD) or common bile duct (CBD) obstruction based on MRI or / and endoscopic
      ultrasound (EUS).

      Patients with PEI (FE1 <200) receive Pertzye or placebo in a cross-over fashion, each for 4
      weeks.

      Body weight, body mass index (BMI), body composition (Bioimpedance), are measured at the time
      of diagnosis of PEI and at 4 and 10 weeks of cross-over treatment. Baseline measurement of
      Vitamin D-25, Vitamin A, iron (ferritin, total iron binding capacity (TIBC), iron), Vitamin
      B12,Tissue transglutaminase IgA (tTG) with total Immunoglobulin A (IgA).

      Quality of Life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the
      Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas
      cancer (FACT-Hep) for physical, social, emotional, and functional quality of life.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Body Weight
time frame: Baseline, 4 weeks, 10 weeks
description: Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
measure: Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks
time frame: Baseline, 4 weeks
description: Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).
measure: Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks
time frame: Baseline, 10 weeks
description: Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).
measure: Change in Body Weight Composition
time frame: Baseline, 4 weeks, 10 weeks
description: Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
arm group label: Placebo First, then Pancrelipase
arm group type: Experimental
description: Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).
arm group label: Pancrelipase First, then Placebo
arm group type: Experimental
description: Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).
intervention type: Drug
intervention name: Pancrelipase
description: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
arm group label: Pancrelipase First, then Placebo
arm group label: Placebo First, then Pancrelipase
other name: Pertzye
intervention type: Drug
intervention name: Placebo Oral Capsule
description: Placebo Oral Capsule
arm group label: Pancrelipase First, then Placebo
arm group label: Placebo First, then Pancrelipase
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Massimo Raimondo, MD
role: Principal Investigator
affiliation: Professor of Medicine
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
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PMID: 11980994
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PMID: 6305473
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PMID: 22749648
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PMID: 24717227
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PMID: 6549746
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PMID: 7195437
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PMID: 9505892
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PMID: 1777547
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PMID: 10415875
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PMID: 431121
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PMID: 510089
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PMID: 3633631
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PMID: 2408983
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PMID: 830926
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PMID: 9057197
citation: Seiler CM, Izbicki J, Varga-Szabo L, Czako L, Fiok J, Sperti C, Lerch MM, Pezzilli R, Vasileva G, Pap A, Varga M, Friess H. Randomised clinical trial: a 1-week, double-blind, placebo-controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1-year open-label extension. Aliment Pharmacol Ther. 2013 Apr;37(7):691-702. doi: 10.1111/apt.12236. Epub 2013 Feb 5.
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PMID: 21418260
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Massimo Raimondo, M.D.
investigator title: Professor, College of Medicine
mesh term: Pancreatic Neoplasms
mesh term: Exocrine Pancreatic Insufficiency
mesh term: Pancrelipase
mesh term: Pancreatin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 