Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: two complex naturopathic add-on therapies, leaflet 5-a-day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: two complex naturopathic add-on therapies, leaflet 5-a-day|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Chemotherapy, Phytotherapy, Nutritional counseling