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

NCT ID: NCT00176046

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31
• Study Completion Date: 2009-07-31

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.

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

viscum album pini

immediate start of treatment with Iscador P s.c.

Group Type: EXPERIMENTAL

viscum album pini

Intervention Type: DRUG

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

waiting group

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

Group Type: ACTIVE_COMPARATOR

viscum album pini

Intervention Type: DRUG

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

Interventions

viscum album pini

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

Intervention Type: DRUG

viscum album pini

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

Intervention Type: DRUG

Other Intervention Names

Iscador P serie 0, 1, 2; Iscador P Serie 0, 1, 2

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Verein für Krebsforschung, Arlesheim, Swizzerland

UNKNOWN

Sponsor Role: collaborator

Weleda AG, D-73525 Schwäbisch Gmünd

UNKNOWN

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Cornelia von Hagens

Head Complementary & Integrative Medicine, Dep. 4.2

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cornelia U. von Hagens, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Complementary and Integrative Medicine

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

WD 40

Identifier Type: -

Identifier Source: org_study_id