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The Pancreatic Enzymes After Gastrectomy Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06058442
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Albrecht Hoffmeister, University of Leipzig

Study Description
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Brief Summary:
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.

Condition or disease Intervention/treatment Phase
Gastrectomy Drug: NORTASE® Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Pancreatic Enzymes After Gastrectomy Trial
Actual Study Start Date : January 24, 2024
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: NORTASE® Drug: NORTASE®
10-15 capsules of NORTASE® per day - over 6 months
Placebo Comparator: Placebo Drug: Placebo
10-15 capsules of placebo per day - over 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Disease specific quality of life (QOL) [ Time Frame: 6 months ]
    This is the physical sub-score from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30) and ranges from 0 (lowest physical functioning) to 100 (highest physical functioning).


Secondary Outcome Measures :
  1. Nutritional supplementation or weight loss [ Time Frame: 6 months ]
    Proportion of patients who receive supplemental nutrition after the run-in period of 3 weeks or have > 10% weight loss at six months

  2. Weight [ Time Frame: 6 months ]
    Percent weight-change at six months (weight in kilograms)

  3. Serum haemoglobin [ Time Frame: 6 months ]
    Concentration of serum haemoglobin

  4. Total protein [ Time Frame: 6 months ]
    Concentration of total protein

  5. Albumin [ Time Frame: 6 months ]
    Concentration of albumin

  6. Glucose [ Time Frame: 6 months ]
    Concentration of glucose

  7. HbA1c [ Time Frame: 6 months ]
    Concentration of HbA1c

  8. Cholesterol [ Time Frame: 6 months ]
    Concentration of cholesterol

  9. Vitamin A [ Time Frame: 6 months ]
    Concentration of vitamin A

  10. Vitamin B12 [ Time Frame: 6 months ]
    Concentration of vitamin B12

  11. Vitamin D [ Time Frame: 6 months ]
    Concentration of vitamin D

  12. Vitamin E [ Time Frame: 6 months ]
    Concentration of vitamin E

  13. Vitamin K [ Time Frame: 6 months ]
    Concentration of vitamin K


Other Outcome Measures:
  1. Faecal elastase-1 [ Time Frame: 6 months ]
    Concentration of faecal elastase-1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gastrectomy (total and partial)
  2. Age 18 or older
  3. Written informed consent

Exclusion Criteria:

  1. Indication for pancreas enzyme therapy
  2. Gastrectomy with palliative intention
  3. UICC (Union for International Cancer Control) Stage IV gastric malignancy
  4. Malnutrition of other aetiology
  5. Life expectancy < 12 months
  6. Known lactose intolerance
  7. Known hereditary galactose intolerance
  8. Patients on alpha-glucosidase inhibitors (AGIs)
  9. Acute pancreatitis
  10. Acute episode of chronic pancreatitis
  11. Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®
  12. Participation in competing interventional trials may be allowed under circumstances
  13. Patients under legal supervision or guardianship
  14. Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor
  15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
  16. Pregnant or nursing women
  17. Suspected lack of compliance
  18. Patients who were already enrolled in the trial
Contacts and Locations
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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): NCT06058442


Contacts
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Contact: Albrecht Hoffmeister, Prof. Dr. 004934197 ext 12240 Albrecht.Hoffmeister@medizin.uni-leipzig.de
Contact: Anett Schmiedeknecht, Dr. 0049 34197 ext 16256 anett.schmiedeknecht@zks.uni-leipzig.de

Locations
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Germany
Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik Recruiting
Cottbus, Germany, 03048
Contact: Tobias Kleemann, Dr.    +493554679427    t.kleemann@ctk.de   
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Active, not recruiting
Dresden, Germany, 01307
Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie Active, not recruiting
Jena, Germany, 07740
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Albrecht Hoffmeister, Prof. Dr.    +4934197 ext 12240    Albrecht.Hoffmeister@medizin.uni-leipzig.de   
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Albrecht Hoffmeister, Prof. Dr. Universität Leipzig
More Information
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Responsible Party: Albrecht Hoffmeister, Prof. Dr. med., University of Leipzig
ClinicalTrials.gov Identifier: NCT06058442    
Other Study ID Numbers: PANEM
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024

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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 Albrecht Hoffmeister, University of Leipzig:
enzyme supplementation
lipase
elastase
gastrointestinal
quality of life