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

Heidelberg University

Status and phase: Completed; Phase 4

Conditions: Metastatic Breast Cancer

Treatments: Drug: viscum album pini

Study type: Interventional

Funder types: Other

Identifiers

NCT00176046

WD 40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

viscum album pini

Experimental group

Description:

immediate start of treatment with Iscador P s.c.

Treatment:

Drug: viscum album pini

Drug: viscum album pini

waiting group

Active Comparator group

Description:

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

Treatment:

Drug: viscum album pini

Drug: viscum album pini