Gastrectomy
Conditions
Keywords
enzyme supplementation, lipase, elastase, gastrointestinal, quality of life
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.
Interventions
DRUGNORTASE®
10-15 capsules of NORTASE® per day - over 6 months
DRUGPlacebo
10-15 capsules of placebo per day - over 6 months
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Gastrectomy (total and partial distal); at least \> 50 % of the stomach must be resected 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Weight | 6 months | Percent weight-change at six months (weight in kilograms) |
| Serum haemoglobin | 6 months | Concentration of serum haemoglobin |
| Total protein | 6 months | Concentration of total protein |
| Albumin | 6 months | Concentration of albumin |
| Glucose | 6 months | Concentration of glucose |
| HbA1c | 6 months | Concentration of HbA1c |
| Cholesterol | 6 months | Concentration of cholesterol |
| Vitamin A | 6 months | Concentration of vitamin A |
| Vitamin B12 | 6 months | Concentration of vitamin B12 |
| Vitamin D | 6 months | Concentration of vitamin D |
| Vitamin E | 6 months | Concentration of vitamin E |
| Vitamin K | 6 months | Concentration of vitamin K |
Countries
Germany
Contacts
CONTACTAlbrecht Hoffmeister, Prof. Dr.
CONTACTAnett Schmiedeknecht, Dr.
PRINCIPAL_INVESTIGATORAlbrecht Hoffmeister, Prof. Dr.
Universität Leipzig
Outcome results
None listed