This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments viscum album pini
Phase phase 4
Sponsor Heidelberg University
Collaborator Verein für Krebsforschung, Arlesheim, Swizzerland
Start date May 1999
End date June 2009
Trial size 114 participants
Trial identifier NCT00176046, WD 40


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
immediate start of treatment with Iscador P s.c.
viscum album pini Iscador P serie 0, 1, 2
s.c. injection of 0,001-20 mg 3 times per week
(Active Comparator)
identical treatment with Iscador P s.c. after waiting period of 3 months
viscum album pini Iscador P Serie 0, 1, 2
s.c. injection 0,001-20 mg 3 times per week

Primary Outcomes

blood count
time frame: 6-30 months
time frame: 6-30 months
lymphocyte stimulation
time frame: 4 months
quality of life
time frame: 6-30 months
anxiety and depression
time frame: 6-30 months
diurnal profile of cortisol
time frame: 6-30 months
expression of zeta-chains on T- and NK-cells
time frame: 6-30 months

Secondary Outcomes

local reactions
time frame: 6-30 months
documentation of concomitant medication
time frame: 6-30 months
documentation of concomitant therapies
time frame: 6-30 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Cornelia U. von Hagens, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Heidelberg University.