Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00160901
- Lead Sponsor
- Heidelberg University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- Indication for chemotherapy for breast cancer for at least 3 cycles
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Department of Complementary and Integrative Medicine
🇩🇪Heidelberg, Baden-Württemberg, Germany