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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176046
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 8, 2017
Verein für Krebsforschung, Arlesheim, Swizzerland
Weleda AG, D-73525 Schwäbisch Gmünd
Information provided by (Responsible Party):
Cornelia von Hagens, 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: viscum album pini Phase 4

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  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 1999
Primary Completion Date : June 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: viscum album pini
immediate start of treatment with Iscador P s.c.
Drug: viscum album pini
s.c. injection of 0,001-20 mg 3 times per week
Other Name: Iscador P serie 0, 1, 2
Active Comparator: waiting group
identical treatment with Iscador P s.c. after waiting period of 3 months
Drug: viscum album pini
s.c. injection 0,001-20 mg 3 times per week
Other Name: Iscador P Serie 0, 1, 2

Primary Outcome Measures :
  1. blood count [ Time Frame: 6-30 months ]
  2. lymphocytes [ Time Frame: 6-30 months ]
  3. lymphocyte stimulation [ Time Frame: 4 months ]
  4. quality of life [ Time Frame: 6-30 months ]
  5. anxiety and depression [ Time Frame: 6-30 months ]
  6. diurnal profile of cortisol [ Time Frame: 6-30 months ]
  7. expression of zeta-chains on T- and NK-cells [ Time Frame: 6-30 months ]

Secondary Outcome Measures :
  1. local reactions [ Time Frame: 6-30 months ]
  2. documentation of concomitant medication [ Time Frame: 6-30 months ]
  3. documentation of concomitant therapies [ Time Frame: 6-30 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176046

Department of Complementary and Integrative Medicine
Heidelberg, Baden-Württemberg, Germany, D-69120
Sponsors and Collaborators
Heidelberg University
Verein für Krebsforschung, Arlesheim, Swizzerland
Weleda AG, D-73525 Schwäbisch Gmünd
Principal Investigator: Cornelia U. von Hagens, MD Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg

Responsible Party: Cornelia von Hagens, Head Complementary & Integrative Medicine, Dep. 4.2, Heidelberg University Identifier: NCT00176046     History of Changes
Other Study ID Numbers: WD 40
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: June 2009

Keywords provided by Cornelia von Hagens, Heidelberg University:
breast cancer
complementary therapy
quality of life
immune function
breast cancer (UICC stage I/II)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Viscum album peptide
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents