NCT00176046

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	viscum album pini	s.c. injection of 0,001-20 mg 3 times per week
DRUG	viscum album pini	s.c. injection 0,001-20 mg 3 times per week

Timeline

• Start date: 1999-05-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2005-09-15
• Last updated: 2017-05-08

Locations

1 site across 1 country: Germany