Mistletoe Extract in Early or Advanced Breast Cancer, a Randomized Feasibility Study - Full Text View

Sponsors and Collaborators:	University of Heidelberg Verein für Krebsforschung, Arlesheim, Swizzerland Weleda AG, D-73525 Schwäbisch Gmünd
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00176046

Purpose

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
Metastatic Breast Cancer	Drug: s. c. injection of an extract of viscum album	Phase IV

Genetics Home Reference related topics: breast cancer

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

Drug Information available for: Viscumin

U.S. FDA Resources

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

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

blood count
lymphocytes
lymphocyte stimulation
Quality of life
Anxiety and depression
diurnal profile of cortisol
expression of zeta-chains on T- and NK-cells

Secondary Outcome Measures:

local reactions
documentation of concomitant medication
documentation of concomitant therapies

Estimated Enrollment:	114
Study Start Date:	May 1999
Estimated Study Completion Date:	June 2009

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

breast cancer
desire for additional therapy with mistletoe extracts

Exclusion Criteria:

contraindication for a therapy with mistletoe extracts(allergy, tuberculosis, hyperthyreosis, acute infectious disease, intracranial pressure in case of tumors or metastasis)
current medication with glucocorticoids or other immunosuppressive therapies
other concomitant complementary therapies
prior therapy with mistletoe extracts > 2 years or during the last 6 months
karnofsky-Index <60

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176046

Locations

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

Sponsors and Collaborators

University of Heidelberg

Verein für Krebsforschung, Arlesheim, Swizzerland

Weleda AG, D-73525 Schwäbisch Gmünd

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:	WD 40
Study First Received:	September 10, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00176046
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission

Keywords provided by University of Heidelberg:

breast cancer
mistletoe
complementary therapy

quality of life
immune function
breast cancer (UICC stage I/II)

Study placed in the following topic categories:

Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009