The Pancreatic Enzymes After Gastrectomy Trial

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

Study Overview

• Status: Recruiting
• Conditions: Gastrectomy
• Intervention / Treatment: Drug: NORTASE®; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anett Schmiedeknecht, Dr.; Phone Number: 16256 0049 34197; Email: anett.schmiedeknecht@zks.uni-leipzig.de
• Study Contact Backup: Name: Albrecht Hoffmeister, Prof. Dr.; Phone Number: 12240 004934197; Email: Albrecht.Hoffmeister@medizin.uni-leipzig.de

Study Locations

• Germany
  • Cottbus, Germany, 03048
    • Recruiting
    • Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik
    • Contact: Tobias Kleemann, Dr.; Phone Number: +493554679427; Email: t.kleemann@ctk.de
  • Dresden, Germany, 01307
    • Active, not recruiting
    • Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
  • Jena, Germany, 07740
    • Active, not recruiting
    • Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie
  • Leipzig, Germany, 04103
    • Recruiting
    • Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig
    • Contact: Albrecht Hoffmeister, Prof. Dr.; Phone Number: 12240 +4934197; Email: Albrecht.Hoffmeister@medizin.uni-leipzig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 10-15 capsules of placebo per day - over 6 months
Experimental: NORTASE®	Drug: NORTASE®; 10-15 capsules of NORTASE® per day - over 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease specific quality of life (QOL)	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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional supplementation or weight loss	Proportion of patients who receive supplemental nutrition after the run-in period of 3 weeks or have > 10% weight loss at six months	6 months
Weight	Percent weight-change at six months (weight in kilograms)	6 months
Serum haemoglobin	Concentration of serum haemoglobin	6 months
Total protein	Concentration of total protein	6 months
Albumin	Concentration of albumin	6 months
Glucose	Concentration of glucose	6 months
HbA1c	Concentration of HbA1c	6 months
Cholesterol	Concentration of cholesterol	6 months
Vitamin A	Concentration of vitamin A	6 months
Vitamin B12	Concentration of vitamin B12	6 months
Vitamin D	Concentration of vitamin D	6 months
Vitamin E	Concentration of vitamin E	6 months
Vitamin K	Concentration of vitamin K	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faecal elastase-1	Concentration of faecal elastase-1	6 months

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Principal Investigator: Albrecht Hoffmeister, Prof. Dr., Universitat Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; gastrointestinal; elastase; lipase; enzyme supplementation
• Other Study ID Numbers: PANEM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No