The Pancreatic Enzymes After Gastrectomy Trial

• Sponsor: University of Leipzig (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06058442
• Collaborator: (none)
• Enrollment: 188
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Pancreatic Enzymes After Gastrectomy Trial
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2026
• Anticipated Study Completion Date: Apr 1, 2026

Arms and Interventions

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

Primary Outcome Measures

1. Disease specific quality of life (QOL) [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 [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 [6 months]

   Percent weight-change at six months (weight in kilograms)

3. serum haemoglobin [6 months]

4. total protein [6 months]

5. albumine [6 months]

6. glucose [6 months]

7. HbA1c [6 months]

8. cholesterol [6 months]

9. vitamin A [6 months]

10. vitamin B12 [6 months]

11. vitamin D [6 months]

12. vitamin E [6 months]

13. vitamins K [6 months]

Other Outcome Measures

1. faecal elastase-1 [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig	Leipzig		Germany	04103

Sponsors and Collaborators

• University of Leipzig

Investigators

• Principal Investigator: Albrecht Hoffmeister, Prof. Dr., Universität Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Albrecht Hoffmeister, Prof. Dr. med., University of Leipzig
• ClinicalTrials.gov Identifier: NCT06058442
• Other Study ID Numbers: PANEM
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Albrecht Hoffmeister, Prof. Dr. med., University of Leipzig: enzyme supplementation; lipase; elastase; gastrointestinal; quality of life

Study Results

No Results Posted as of Sep 28, 2023