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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160901
• Other study ID #: M16
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: April 18, 2007
• Start date: August 2003
• Est. completion date: December 2005

Study information

• Verified date: March 2007
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• two complex naturopathic add-on therapies, leaflet 5-a-day

Locations

Country	Name	City	State
Germany	Department of Complementary and Integrative Medicine	Heidelberg	Baden-Württemberg

Sponsors (5)

Lead Sponsor	Collaborator
Heidelberg University	Cefak KG, Kempten, H. W. & J. Hector-Stiftung, Weinheim, Schwabe-Wenex International Ltd, Ursapharm, Saarbrücken

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in general QOL 3-5 weeks after and before three cycles of chemotherapy
Secondary	Difference in anxiety and depression measured by HADS-D 3-5 weeks after and before three cycles of chemotherapy
Secondary	Sensitivities measured by the perimed sensitivity questionnaire
Secondary	Creatinin
Secondary	ALAT
Secondary	Coagulation time
Secondary	Selenium