NCT00160901

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: Heidelberg University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	two complex naturopathic add-on therapies, leaflet 5-a-day

Timeline

• Start date: 2003-08-01
• Completion: 2005-12-01
• First posted: 2005-09-12
• Last updated: 2007-04-19

Locations

1 site across 1 country: Germany