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PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

Sponsor
Massimo Raimondo, M.D. (Other)
Overall Status
Terminated
CT.gov ID
NCT02985801
Collaborator
Digestive Care, Inc. (Industry)
16
Enrollment
1
Location
2
Arms
28
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pancreatic Enzyme Replacement Therapy (PERT) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Placebo First, then Pancrelipase

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).

Drug: Pancrelipase
Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
Other Names:
  • Pertzye

    • Drug: Placebo Oral Capsule
    Placebo Oral Capsule
    Experimental: Pancrelipase First, then Placebo

    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).

    Drug: Pancrelipase
    Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
    Other Names:
  • Pertzye

    • Drug: Placebo Oral Capsule
    Placebo Oral Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Change in Body Weight [Baseline, 4 weeks, 10 weeks]

      Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.

    Secondary Outcome Measures

    1. Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks [Baseline, 4 weeks]

      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).

    2. Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks [Baseline, 10 weeks]

      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).

    3. Change in Body Weight Composition [Baseline, 4 weeks, 10 weeks]

      Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients 18-80 years

    • Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis)

    • On established chemotherapy regimen for pancreas cancer, which will be continued over the time of study

    • Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool

    Exclusion Criteria:

    • Common bile duct obstruction resulting in obstructive jaundice

    • Celiac disease

    • Crohn's disease

    • Benign pancreatic conditions

    • Bowel obstruction

    • Surgically altered bowel anatomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Massimo Raimondo, M.D.
    • Digestive Care, Inc.

    Investigators

    • Principal Investigator: Massimo Raimondo, MD, Professor of Medicine

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Massimo Raimondo, M.D., Professor, College of Medicine, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02985801
    Other Study ID Numbers:
    • 15-008713
    First Posted:
    Dec 7, 2016
    Last Update Posted:
    Mar 15, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Exocrine Pancreatic Insufficiency
    Pancrelipase
    Pancreatin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Placebo First, Then Pancrelipase Pancrelipase First, Then Placebo
    Arm/Group 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). Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units Placebo Oral Capsule: Placebo Oral Capsule 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). Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units Placebo Oral Capsule: Placebo Oral Capsule
    Period Title: Overall Study
    STARTED 8 8
    COMPLETED 8 8
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Placebo First, Then Pancrelipase Pancrelipase First, Then Placebo Total
    Arm/Group 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). Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units Placebo Oral Capsule: Placebo Oral Capsule 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). Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units Placebo Oral Capsule: Placebo Oral Capsule Total of all reporting groups
    Overall Participants 8 8 16
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62.1
    (7.6)
    68.3
    (6.9)
    65.2
    (9.4)
    Sex: Female, Male (Count of Participants)
    Female
    5
    62.5%
    4
    50%
    9
    56.3%
    Male
    3
    37.5%
    4
    50%
    7
    43.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    12.5%
    0
    0%
    1
    6.3%
    White
    7
    87.5%
    8
    100%
    15
    93.8%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    8
    100%
    8
    100%
    16
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change in Body Weight
    Description Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
    Time Frame Baseline, 4 weeks, 10 weeks

    Outcome Measure Data

    Analysis Population Description
    Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
    Arm/Group Title Placebo Pancrelipase
    Arm/Group Description Subjects who received placebo oral capsule in either the first or last 4 weeks of the study Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study
    Measure Participants 0 0
    2. Secondary Outcome
    Title Change in Quality of Life Score as Measured by FACT-Hep Scale at 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).
    Time Frame Baseline, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
    Arm/Group Title Placebo Pancrelipase
    Arm/Group Description Subjects who received placebo oral capsule in either the first or last 4 weeks of the study Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study
    Measure Participants 0 0
    3. Secondary Outcome
    Title Change in Quality of Life Score as Measured by FACT-Hep Scale at 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).
    Time Frame Baseline, 10 weeks

    Outcome Measure Data

    Analysis Population Description
    Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
    Arm/Group Title Placebo Pancrelipase
    Arm/Group Description Subjects who received placebo oral capsule in either the first or last 4 weeks of the study Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study
    Measure Participants 0 0
    4. Secondary Outcome
    Title Change in Body Weight Composition
    Description Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
    Time Frame Baseline, 4 weeks, 10 weeks

    Outcome Measure Data

    Analysis Population Description
    Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
    Arm/Group Title Placebo Pancrelipase
    Arm/Group Description Subjects who received placebo oral capsule in either the first or last 4 weeks of the study Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study
    Measure Participants 0 0

    Adverse Events

    Time Frame Adverse events were collected from baseline to end of study for a total of approximately 10 weeks on all participants.
    Adverse Event Reporting Description
    Arm/Group Title Placebo Pancrelipase
    Arm/Group Description Subjects who received placebo oral capsule in either the first or last 4 weeks of the study Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study
    All Cause Mortality
    Placebo Pancrelipase
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/8 (0%)
    Serious Adverse Events
    Placebo Pancrelipase
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/8 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo Pancrelipase
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/8 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Dr. Massimo Raimondo
    Organization Mayo Clinic
    Phone 904-953-6982
    Email Raimondo.Massimo@mayo.edu
    Responsible Party:
    Massimo Raimondo, M.D., Professor, College of Medicine, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02985801
    Other Study ID Numbers:
    • 15-008713
    First Posted:
    Dec 7, 2016
    Last Update Posted:
    Mar 15, 2021
    Last Verified:
    Feb 1, 2021