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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


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

blood count

Outcome Time Frame:

6-30 months

Safety Issue:

No

Principal Investigator

Cornelia U. von Hagens, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

WD 40

NCT ID:

NCT00176046

Start Date:

May 1999

Completion Date:

December 2009

Related Keywords:

  • Metastatic Breast Cancer
  • breast cancer
  • mistletoe
  • complementary therapy
  • quality of life
  • immune function
  • breast cancer (UICC stage I/II)
  • Breast Neoplasms

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