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The purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemotherapy on body weight, body composition, nutritional status and physical function compared to a standard nutrition formula. Using an adaptive design approximately 80 patients will be randomized in the first part of the study. Following an interim analysis further 160 patients may be added, for a total of 240 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Supportan(R) (500 ml)/disease-specific enteral tube feed for oncologic patients with special key substrates |
|
| Control | Placebo Comparator | Fresubin(R) energy fibre (500 ml)/a nutritionally complete enteral standard feed (isoenergetic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes) | Dietary Supplement | 500 ml per day / treatment period 11-14 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body cell mass measured by bioelectrical impedance spectroscopy (BIS) | Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period |
| Measure | Description | Time Frame |
|---|---|---|
| Other parameters of body composition such as fat free mass, lipid mass, total body water, intracellular water, lean tissue mass | Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period | |
| Hand grip strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Fietkau, Prof. Dr. | Department of Radiotherapy University hospital of Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO | Bremen | D-28239 | Germany | |||
| Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23765693 | Derived | Fietkau R, Lewitzki V, Kuhnt T, Holscher T, Hess CF, Berger B, Wiegel T, Rodel C, Niewald M, Hermann RM, Lubgan D. A disease-specific enteral nutrition formula improves nutritional status and functional performance in patients with head and neck and esophageal cancer undergoing chemoradiotherapy: results of a randomized, controlled, multicenter trial. Cancer. 2013 Sep 15;119(18):3343-53. doi: 10.1002/cncr.28197. Epub 2013 Jun 13. |
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| Fresubin(R) | Dietary Supplement | 500 ml/a nutritionally complete enteral standard feed (isoenergetic) |
|
| Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period |
| Quality of Life | Baseline, end of radio-/chemotherapy, day 49 of convalescence period |
| Gastrointestinal tolerance | Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily |
| Dresden |
| D-01307 |
| Germany |
| Department of Radiotherapy, University hospital | Erlangen | D-91054 | Germany |
| Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt | Frankfurt | D-60590 | Germany |
| Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen | Göttingen | D-37075 | Germany |
| Klinik für Strahlentherapie, Universitätsklinikum Halle | Halle | D-06097 | Germany |
| Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes | Homburg (Saar) | D-66421 | Germany |
| Klinik und Poliklinik für Strahlentherapie Universität Rostock | Rostock | D-18059 | Germany |
| Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen | Tübingen | D-72076 | Germany |
| Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm | Ulm | D-89081 | Germany |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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