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

This study has been completed.

Sponsor:

Collaborators:

H. W. & J. Hector-Stiftung, Weinheim

Cefak KG, Kempten

Ursapharm, Saarbrücken

Schwabe-Wenex International Ltd

Information provided by:

University of Heidelberg

ClinicalTrials.gov Identifier:

NCT00160901

First received: September 8, 2005

Last updated: April 18, 2007

Last verified: March 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

April 18, 2007

Start Date ^ICMJE

August 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

difference in the sum score of the most common side effects of a chemotherapy(fatigue, nausea, loss of appetite, obstipation, diarrhea)measured by the EORTC QLQ C30 3-5 weeks after and before 3 cycles of chemotherapy

Change History

Complete list of historical versions of study NCT00160901 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

December 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00160901

Other Study ID Numbers ^ICMJE

M16

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

H. W. & J. Hector-Stiftung, Weinheim
Cefak KG, Kempten
Ursapharm, Saarbrücken
Schwabe-Wenex International Ltd

Investigators ^ICMJE

Principal Investigator:

Cornelia U. von Hagens, MD

Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg

Information Provided By

University of Heidelberg

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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