Trial record 10 of 103 for:    (complementary OR alternative) medicine AND (woman OR women OR female) | cancer

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
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 April 17, 2014