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Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About 70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like cancer often results in a reduced availability of iron for the body. In clinical practice iron substitution is usually administered orally. Due to low resorption rates, frequent gastric side effects and thus poor patient compliance a parenteral substitution seems to be a better option in terms of efficacy. In the framework of a randomized multicenter clinical trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron substitution will now be conducted in order to identify the best treatment form for clinical practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in both treatment arms for effect comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FERRIC CARBOXYMALTOSE | Experimental | max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week). |
|
| ferro sanol(R) duodenal 100 mg | Active Comparator | 200 mg ferro sanol per day over 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FerInject | Drug | FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rise or normalization of hemoglobin | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue as measured by EORTC-QLQ-FA13 | 12 weeks | |
| Quality of life as measured by EORTC-C30 | 12 weeks | |
| Handgrip strength as measured by Hydraulic Hand Dynamometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research | Frankfurt am Main | Hesse | 60488 | Germany | ||
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| Label | URL |
|---|---|
| Related Info | View source |
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No IPD will be shared.
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| Ferro sanol | Drug | 200 mg ferro sanol per day over 12 weeks |
|
| 12 weeks |
| Number of allogenic blood transfusions (in total and per patient) | 12 weeks |
| Time until rise or normalisation of hemoglobin | 12 weeks |
| Genesis of the iron deficiency anemia | 12 weeks |
| Number of therapy with recombinant erythropoietin | 12 weeks |
| Dose of therapy with recombinant erythropoietin | 12 weeks |
| Duration of therapy with recombinant erythropoietin | 12 weeks |
| Inflammatory parameters | 12 weeks |
| Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002) | 12 weeks |
| Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002) | 12 weeks |
| Tolerance | 12 weeks |
| Incidence and severity of adverse events | incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 4 criteria as assessed at day 1, 8, 15, 36, 50 and 64 and at end of treatment. | 12 weeks |
| Dropout rate due to toxicity or patient will | 12 weeks |
| Overall survival | 12 weeks |
| Klinikum Aschaffenburg |
| Aschaffenburg |
| 63739 |
| Germany |
| Klinikum Bayreuth | Bayreuth | 85445 | Germany |
| Augusta-Krankenanstalt gGmbH | Bochum | 44791 | Germany |
| Medizinische Universitaetsklinik Bochum | Bochum | 44892 | Germany |
| Krankenhaus Dresden-Friedrichstadt | Dresden | 01067 | Germany |
| Universitätsklinikum Dresden | Dresden | 01307 | Germany |
| Kliniken Essen Mitte | Essen | 45136 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Universitätsklinik Halle-Wittenberg | Halle | 06120 | Germany |
| Universitätskrankenhaus Eppendorf | Hamburg | 20246 | Germany |
| NCT Heidelberg | Heidelberg | 69120 | Germany |
| Gemeinschaftsklinikum Mittelrhein GmbH | Koblenz | 56068 | Germany |
| Universitätsmedizin Mannheim | Mannheim | 68167 | Germany |
| Klinikum rechts der Isar | Munich | 81675 | Germany |
| Klinikum Bogenhausen | Munich | 81925 | Germany |
| Elblandklinikum Riesa | Riesa | 01589 | Germany |
| Caritas Klinikum St. Theresia | Saarbrücken | 66113 | Germany |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| C030676 | ferroglycine sulfate |
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