Mistletoe Extract in Early or Advanced Breast Cancer, A Feasibility Study
May 3, 2017 updated by: Cornelia von Hagens, Heidelberg University
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
114
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
-
Heidelberg, Baden-Württemberg, Germany, D-69120
- Department of Complementary and Integrative Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: viscum album pini
immediate start of treatment with Iscador P s.c.
|
s.c.
injection of 0,001-20 mg 3 times per week
Other Names:
s.c.
injection 0,001-20 mg 3 times per week
Other Names:
|
|
Active Comparator: waiting group
identical treatment with Iscador P s.c. after waiting period of 3 months
|
s.c.
injection of 0,001-20 mg 3 times per week
Other Names:
s.c.
injection 0,001-20 mg 3 times per week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
blood count
Time Frame: 6-30 months
|
6-30 months
|
|
lymphocytes
Time Frame: 6-30 months
|
6-30 months
|
|
lymphocyte stimulation
Time Frame: 4 months
|
4 months
|
|
quality of life
Time Frame: 6-30 months
|
6-30 months
|
|
anxiety and depression
Time Frame: 6-30 months
|
6-30 months
|
|
diurnal profile of cortisol
Time Frame: 6-30 months
|
6-30 months
|
|
expression of zeta-chains on T- and NK-cells
Time Frame: 6-30 months
|
6-30 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
local reactions
Time Frame: 6-30 months
|
6-30 months
|
|
documentation of concomitant medication
Time Frame: 6-30 months
|
6-30 months
|
|
documentation of concomitant therapies
Time Frame: 6-30 months
|
6-30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cornelia U. von Hagens, MD, Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 1999
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
September 10, 2005
First Submitted That Met QC Criteria
September 10, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
May 8, 2017
Last Update Submitted That Met QC Criteria
May 3, 2017
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WD 40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.