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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: viscum album pini
* Drug: viscum album pini


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: viscum album pini<br>immediate start of treatment with Iscador P s.c. | Drug: viscum album pini<br>* s.c. injection of 0,001-20 mg 3 times per week<br>* Other names: Iscador P serie 0, 1, 2;|
| Active Comparator: waiting group<br>identical treatment with Iscador P s.c. after waiting period of 3 months | Drug: viscum album pini<br>* s.c. injection 0,001-20 mg 3 times per week<br>* Other names: Iscador P Serie 0, 1, 2;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local reactions |  | 6-30 months | 
| documentation of concomitant medication |  | 6-30 months | 
| documentation of concomitant therapies |  | 6-30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, mistletoe, complementary therapy, quality of life, immune function, breast cancer (UICC stage I/II)