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.

Condition	Intervention	Phase
new indication for a primary or secondary chemotherapy for breast cancer last chemotherapy before > 12 months	Drug: selenium, milk thistle, goldenrod, bromelain and/or individual counseling on nutrition and physical activity, leaflet 5-a-day	Phase IV

Further Study Details: 

Primary Outcomes: difference in the sum score of the most common side effects of a chemotherapy(fatigue, nausea, loss of appetite, obstipation, diarrhea)measured by the EORTC QLQ C30 3-5 weeks after and before 3 cycles of chemotherapy
Secondary Outcomes: 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; sensitivities measured by the perimed sensitivity questionnaire; creatinin; ALAT; coagulation time; Selenium
Expected Total Enrollment:  150

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• indication for chemotherapy for breast cancer for at least 3 cycles

Exclusion Criteria:

• prior chemotherapy within 12 months
• use of herbal or nutrional supplements or other complementary therapies 7 days before and during study inclusion
• selenium intoxication
• current use of any medication influencing the coagulation system
• edema in case of impaired cardial or renal function
• other severe medical condition
• psychiatric disorders
• regular fluid intake < 2000 ml per day

Please refer to this study by ClinicalTrials.gov identifier  NCT00160901

Bettina Reinhard-Hennch, MD      0049-568325    bettina_reinhard-hennch@med.uni-heidelberg.de

Germany, Baden-Württemberg
      Department of Complementary and Integrative Medicine, Heidelberg,  Baden-Württemberg,  D-69115,  Germany; Recruiting

Study chairs or principal investigators

Cornelia U. von Hagens, MD,  Principal Investigator,  Department of Complementary and Integrative Medicine Women''''s Hospital, University of Heidelberg   

Study ID Numbers:  M16
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00160901
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices; Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2005-09-13