Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg
18 Years
75 Years
Female
Breast Cancer
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
Cornelia U. von Hagens, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
M16
NCT ID:
NCT00160901
Start Date:
August 2003
Completion Date:
December 2005
Related Keywords:
- Breast Cancer
- Breast cancer
- Chemotherapy
- Phytotherapy
- Nutritional counseling
- Breast Neoplasms
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