Mistletoe Extract in Early or Advanced Breast Cancer, A Feasibility Study

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00176046

Enrollment

114

Registered

2005-09-15

Start date

1999-05-31

Completion date

2009-07-31

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

breast cancer, mistletoe, complementary therapy, quality of life, immune function, breast cancer (UICC stage I/II)

Brief summary

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.

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.

Interventions

DRUGviscum album pini

s.c. injection of 0,001-20 mg 3 times per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
documentation of concomitant medication	6-30 months
documentation of concomitant therapies	6-30 months
local reactions	6-30 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026