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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Heidelberg University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Verein für Krebsforschung, Arlesheim, Swizzerland
Weleda AG, D-73525 Schwäbisch Gmünd
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00176046
First received: September 10, 2005
Last updated: February 9, 2011
Last verified: June 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Heidelberg University:

Primary Outcome Measures:
  • blood count [ Time Frame: 6-30 months ] [ Designated as safety issue: No ]
  • lymphocytes [ Time Frame: 6-30 months ] [ Designated as safety issue: No ]
  • lymphocyte stimulation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 6-30 months ] [ Designated as safety issue: No ]
  • anxiety and depression [ Time Frame: 6-30 months ] [ Designated as safety issue: No ]
  • diurnal profile of cortisol [ Time Frame: 6-30 months ] [ Designated as safety issue: No ]
  • expression of zeta-chains on T- and NK-cells [ Time Frame: 6-30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • local reactions [ Time Frame: 6-30 months ] [ Designated as safety issue: Yes ]
  • documentation of concomitant medication [ Time Frame: 6-30 months ] [ Designated as safety issue: No ]
  • documentation of concomitant therapies [ Time Frame: 6-30 months ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: May 1999
Estimated Study Completion Date: December 2009
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176046

Locations
Germany
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Württemberg, Germany, D-69115
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

No publications provided

Responsible Party: v. Hagens, Cornelia, MD, Complementary&Integrative Medicine
ClinicalTrials.gov Identifier: NCT00176046     History of Changes
Other Study ID Numbers: WD 40
Study First Received: September 10, 2005
Last Updated: February 9, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 27, 2014