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:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00160901
First received: September 8, 2005
Last updated: April 18, 2007
Last verified: March 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Württemberg, Germany, D-69115
Sponsors and Collaborators
Heidelberg University
H. W. & J. Hector-Stiftung, Weinheim
Cefak KG, Kempten
Ursapharm, Saarbrücken
Schwabe-Wenex International Ltd
Investigators
Principal Investigator: Cornelia U. von Hagens, MD Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
  More Information

No publications provided

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

Keywords provided by Heidelberg University:
Breast cancer
Chemotherapy
Phytotherapy
Nutritional counseling

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014