Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer - Full Text View

Sponsors and Collaborators:	University of Heidelberg H. W. & J. Hector-Stiftung, Weinheim Cefak KG, Kempten Ursapharm, Saarbrücken Bionorica AG
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00160901

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: two complex naturopathic add-on therapies, leaflet 5-a-day	Phase IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Cancer Alternative Therapies Complementary and Alternative Medicine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	150
Study Start Date:	August 2003
Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160901

Locations

Germany, Baden-Württemberg
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Württemberg, Germany, D-69115

Sponsors and Collaborators

University of Heidelberg

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

Cefak KG, Kempten

Ursapharm, Saarbrücken

Bionorica AG

Investigators

Principal Investigator:

Cornelia U. von Hagens, MD

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

More Information

Study ID Numbers:	M16
Study First Received:	September 8, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00160901
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission

Keywords provided by University of Heidelberg:

Breast cancer
Chemotherapy
Phytotherapy
Nutritional counseling

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009