Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer
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.
Drug: two complex naturopathic add-on therapies, leaflet 5-a-day
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg|
- 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
- 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
- Coagulation time
|Study Start Date:||August 2003|
|Study Completion Date:||December 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160901
|Department of Complementary and Integrative Medicine|
|Heidelberg, Baden-Württemberg, Germany, D-69115|
|Principal Investigator:||Cornelia U. von Hagens, MD||Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg|