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Sponsors and Collaborators: |
University of Heidelberg Verein für Krebsforschung, Arlesheim, Swizzerland Weleda AG, D-73525 Schwäbisch Gmünd |
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Information provided by: | University of Heidelberg |
ClinicalTrials.gov Identifier: | NCT00176046 |
The purpose of this feasibility study is to identify appropriate surrogate parameters for a randomized study to examine the efficacy of a complementary therapy with an extract of viscum album (Iscador P) in patients with breast cancer
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: s. c. injection of an extract of viscum album |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Controlled Randomized Feasibility Study on a Treatment With Viscum Album in Patients With Breast Cancer to Identify Appropriate Surrogate Parameters for a Randomized Study of the Efficacy of Treatment With Mistletoe Extracts |
Estimated Enrollment: | 114 |
Study Start Date: | May 1999 |
Estimated Study Completion Date: | June 2009 |
The study consists of three parts. Part 1 is a prospective non-randomized feasibility study in patients with breast cancer after primary surgery during chemotherapy or endocrine therapy comparing blood count, lymphocytes, quality of life and local and general side effects between the groups Part 2 is a prospective randomized feasibility study with a waiting list for three months comparing changes in quality of life, depression, diurnal cortisol profile and expression of zeta-chains in T- and NK-cells after three months of treatment or waiting in patients of two different strata (early breast cancer UICC I/II and metastatic breast cancer) Part 3 consists of two follow-up periods of 12 months respective. Patients may choose to continue, quit or restart mistletoe treatment upon their own decision, endpoints from part 2 are evaluated every 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Baden-Württemberg | |
Department of Complementary and Integrative Medicine | |
Heidelberg, Baden-Württemberg, Germany, D-69115 |
Principal Investigator: | Cornelia U. von Hagens, MD | Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg |
Study ID Numbers: | WD 40 |
Study First Received: | September 10, 2005 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00176046 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission |
breast cancer mistletoe complementary therapy |
quality of life immune function breast cancer (UICC stage I/II) |
Skin Diseases Quality of Life Breast Neoplasms European Mistletoe Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |