Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg
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
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
Cornelia U. von Hagens, MD
Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
Germany: Federal Institute for Drugs and Medical Devices