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Trial record 68 of 2867 for:    Pancreatic Cancer AND pancreas

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

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ClinicalTrials.gov Identifier: NCT02985801
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Digestive Care, Inc.
Information provided by (Responsible Party):
Massimo Raimondo, M.D., Mayo Clinic

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
Pancreatic Insufficiency Pancreatic Cancer Pancreatic Enzyme Abnormality Drug: Pancrelipase Drug: Placebo Oral Capsule 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 : December 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Pertzye

Drug: Placebo Oral Capsule
Placebo Oral Capsule




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02985801


Contacts
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Contact: Andrea C Rodriguez, MD 904 953 6970 Rodriguez.Andrea@mayo.edu
Contact: Bhaumik Brahmbhatt, MBBS 904 783 6982 Brahmbhatt.Bhaumik@mayo.edu

Locations
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United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Massimo Raimondo, MD    904-783-6982    Raimondo.Massimo@mayo.edu   
Contact: Lady Katherine Mejia Perez, MD    904-607-5761    perez.katherine@mayo.edu   
Sponsors and Collaborators
Massimo Raimondo, M.D.
Digestive Care, Inc.
Investigators
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Principal Investigator: Massimo Raimondo, MD Professor of Medicine

Publications:

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Responsible Party: Massimo Raimondo, M.D., Professor, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02985801     History of Changes
Other Study ID Numbers: 15-008713
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Exocrine Pancreatic Insufficiency
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Pancrelipase
Pancreatin
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Agents