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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176046
First Posted: September 15, 2005
Last Update Posted: May 8, 2017
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.
Collaborators:
Verein für Krebsforschung, Arlesheim, Swizzerland
Weleda AG, D-73525 Schwäbisch Gmünd
Information provided by (Responsible Party):
Cornelia von Hagens, Heidelberg University
  Purpose
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 Intervention Phase
Metastatic Breast Cancer Drug: viscum album pini Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cornelia von Hagens, Heidelberg University:

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

Secondary Outcome Measures:
  • local reactions [ Time Frame: 6-30 months ]
  • documentation of concomitant medication [ Time Frame: 6-30 months ]
  • documentation of concomitant therapies [ Time Frame: 6-30 months ]

Enrollment: 114
Actual Study Start Date: May 1999
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00176046


Locations
Germany
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
Investigators
Principal Investigator: Cornelia U. von Hagens, MD Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
  More Information

Responsible Party: Cornelia von Hagens, Head Complementary & Integrative Medicine, Dep. 4.2, Heidelberg University
ClinicalTrials.gov Identifier: NCT00176046     History of Changes
Other Study ID Numbers: WD 40
First Submitted: September 10, 2005
First Posted: September 15, 2005
Last Update Posted: May 8, 2017
Last Verified: June 2009

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

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