Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Heidelberg University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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.
Investigators
Eligibility 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 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
Outcomes
Primary Outcomes
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 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