Breast Cancer
Conditions
Keywords
Breast cancer, Chemotherapy, Phytotherapy, Nutritional counseling
Brief summary
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.
Detailed description
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.
Interventions
DRUGtwo complex naturopathic add-on therapies, leaflet 5-a-day
Sponsors
Hector-Stiftung
Cefak KG, Kempten
Ursapharm, Saarbrücken
Schwabe-Wenex International Ltd
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Indication for chemotherapy for breast cancer for at least 3 cycles
Exclusion criteria
* Prior chemotherapy within 12 months * use of herbal or nutritional supplements or other complementary or alternative medications ≥ 7 days prior to start of chemotherapy and during the trial * allergy to study medication * Selenium intoxication * Current use of cumarins or other medication influencing the coagulation system * Edema in case of impaired cardial or renal function * Other severe medical condition * Psychiatric or central neurological disorders * Regular fluid intake \< 2000 ml per day
Design outcomes
Primary
| Measure | 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in anxiety and depression measured by HADS-D 3-5 weeks after and before three cycles of chemotherapy | — |
| Sensitivities measured by the perimed sensitivity questionnaire | — |
| Creatinin | — |
| Difference in general QOL 3-5 weeks after and before three cycles of chemotherapy | — |
| Coagulation time | — |
| Selenium | — |
| ALAT | — |
Countries
Germany
Outcome results
None listed