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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cornelia U. von Hagens, MD
Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
Germany: Federal Institute for Drugs and Medical Devices