NCT00176046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 1999

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 8, 2017

Status Verified

June 1, 2009

Enrollment Period

10.1 years

First QC Date

September 10, 2005

Last Update Submit

May 3, 2017

Conditions

Metastatic Breast Cancer

Keywords

breast cancermistletoecomplementary therapyquality of lifeimmune functionbreast cancer (UICC stage I/II)

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • local reactions

    6-30 months

  • documentation of concomitant medication

    6-30 months

  • documentation of concomitant therapies

    6-30 months

Study Arms (2)

viscum album pini

EXPERIMENTAL

immediate start of treatment with Iscador P s.c.

Drug: viscum album pini

waiting group

ACTIVE COMPARATOR

identical treatment with Iscador P s.c. after waiting period of 3 months

Drug: viscum album pini

Interventions

viscum album piniDRUG

s.c. injection of 0,001-20 mg 3 times per week

Also known as: Iscador P serie 0, 1, 2
viscum album pini

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • breast cancer
  • desire for additional therapy with mistletoe extracts

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Complementary and Integrative Medicine

Heidelberg, Baden-Wurttemberg, D-69120, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cornelia U. von Hagens, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Complementary & Integrative Medicine, Dep. 4.2

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

May 1, 1999

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

May 8, 2017

Record last verified: 2009-06

Locations

DE(1)