The Pancreatic Enzymes After Gastrectomy Trial

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

Official Title
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The Pancreatic Enzymes After Gastrectomy Trial

Conditions
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Gastrectomy

Intervention / Treatment
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* Drug: NORTASE®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastrectomy (total and partial) Age 18 or older Written informed consent Exclusion Criteria: Indication for pancreas enzyme therapy Gastrectomy with palliative intention UICC (Union for International Cancer Control) Stage IV gastric malignancy Malnutrition of other aetiology Life expectancy < 12 months Known lactose intolerance Known hereditary galactose intolerance Patients on alpha-glucosidase inhibitors (AGIs) Acute pancreatitis Acute episode of chronic pancreatitis Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE® Participation in competing interventional trials may be allowed under circumstances Patients under legal supervision or guardianship Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor 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 Pregnant or nursing women Suspected lack of compliance Patients who were already enrolled in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |  | 6 months | 
| total protein |  | 6 months | 
| albumine |  | 6 months | 
| glucose |  | 6 months | 
| HbA1c |  | 6 months | 
| cholesterol |  | 6 months | 
| vitamin A |  | 6 months | 
| vitamin B12 |  | 6 months | 
| vitamin D |  | 6 months | 
| vitamin E |  | 6 months | 
| vitamins K |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipase, enzyme supplementation, elastase, gastrointestinal, quality of life