Breast Cancer Clinical Trial
Official title:
Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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