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| Name | Class |
|---|---|
| Hector-Stiftung | OTHER |
| Cefak KG, Kempten | UNKNOWN |
| Ursapharm, Saarbrücken | UNKNOWN |
| Schwabe-Wenex International Ltd |
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The purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients.
patients were randomized to receive: (a) individual nutrition consultation with recommendations for physical activity before or on the first day of chemotherapy together with daily oral medication consisting of selenium (sodium-selenit 100 microg/d), milk thistle (silibin 280 mg/d), goldenrod (solidago 1,680g/d) and pineapple enzyme (bromelaine 3.000 F.I.P. units/d) during the first three cycles till 3-5 weeks later, (b) individual nutrition consultation with recommendations for physical activity only and (c) a leaflet "5-a-day" for the control group.
Primary endpoint was the difference of the global health status from the EORTC QLQ-C30 before and 3-5 weeks after the third cycle of chemotherapy. Secondary endpoints were the other subscales of the EORTC QLQ C3o and BR 23 and anxiety and depression from the HADS-D.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| two complex naturopathic add-on therapies, leaflet 5-a-day | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the sum score of the most common side effects of a chemotherapy (fatigue, nausea, loss of appetite, constipation, diarrhea) measured by the EORTC QLQ C30 3-5 weeks after and before 3 cycles of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in general QOL 3-5 weeks after and before three cycles of chemotherapy | ||
| Difference in anxiety and depression measured by HADS-D 3-5 weeks after and before three cycles of chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia U. von Hagens, MD | Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Complementary and Integrative Medicine | Heidelberg | Baden-Wurttemberg | D-69115 | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| INDUSTRY |
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| Sensitivities measured by the perimed sensitivity questionnaire |
| Creatinin |
| ALAT |
| Coagulation time |
| Selenium |
| D017437 |
| Skin and Connective Tissue Diseases |