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

Phase 4

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: viscum album pini

• Registration Number: NCT00176046
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
viscum album pini	viscum album pini	immediate start of treatment with Iscador P s.c.
waiting group	viscum album pini	identical treatment with Iscador P s.c. after waiting period of 3 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
documentation of concomitant medication	6-30 months
local reactions	6-30 months
documentation of concomitant therapies	6-30 months

Trial Locations

Locations (1)

Department of Complementary and Integrative Medicine; 🇩🇪 Heidelberg, Baden-Württemberg, Germany