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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NORTASE® | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NORTASE® | Drug | 10-15 capsules of NORTASE® per day - over 6 months |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal elastase-1 | Concentration of faecal elastase-1 | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albrecht Hoffmeister, Prof. Dr. | Contact | +4934197 | 12240 | Albrecht.Hoffmeister@medizin.uni-leipzig.de |
| Anett Schmiedeknecht, Dr. | Contact | +49 34197 | 16256 | anett.schmiedeknecht@zks.uni-leipzig.de |
| Name | Affiliation | Role |
|---|---|---|
| Albrecht Hoffmeister, Prof. Dr. | Universität Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie | Not yet recruiting | Borna | Germany |
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| ID | Term |
|---|---|
| C059312 | nortase |
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| Placebo |
| Drug |
10-15 capsules of placebo per day - over 6 months |
|
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 |
| Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik | Recruiting | Cottbus | 03048 | Germany |
|
| KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie | Not yet recruiting | Essen | Germany |
|
| UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie | Recruiting | Freiburg im Breisgau | 79106 | Germany |
|
| Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie | Recruiting | Jena | 07740 | Germany |
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| Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig | Recruiting | Leipzig | 04103 | Germany |
|
| Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie | Recruiting | Leipzig | Germany |
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| Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie | Recruiting | Schwerin | 19055 | Germany |
|
| Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm | Recruiting | Ulm | Germany |
|