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

Phase 4

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00160901
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2005-12
• Status Verified: 2007-03
• Last Update Submitted: 2007-04-18
• Last Update Posted: 2007-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Complementary and Integrative Medicine; 🇩🇪 Heidelberg, Baden-Württemberg, Germany