Clinical trial NCT00176046: Mistletoe Extract in Early or Advanced Breast Cancer, A Feasibility Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Breast Cancer
Keywords: breast cancer
mistletoe
complementary therapy
quality of life
immune function
breast cancer (UICC stage I/II)
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Verein für Krebsforschung, Arlesheim, Swizzerland
name: Weleda AG, D-73525 Schwäbisch Gmünd
First posted: 2005-09-15
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: blood count
timeFrame: 6-30 months
measure: lymphocytes
timeFrame: 6-30 months
measure: lymphocyte stimulation
timeFrame: 4 months
measure: quality of life
timeFrame: 6-30 months
measure: anxiety and depression
timeFrame: 6-30 months
measure: diurnal profile of cortisol
timeFrame: 6-30 months
measure: expression of zeta-chains on T- and NK-cells
timeFrame: 6-30 months
Secondary outcomes:
measure: local reactions
timeFrame: 6-30 months
measure: documentation of concomitant medication
timeFrame: 6-30 months
measure: documentation of concomitant therapies
timeFrame: 6-30 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Complementary and Integrative Medicine
state: Baden-Württemberg
Study officials:
affiliation: Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
name: Cornelia U. von Hagens, MD
role: PRINCIPAL_INVESTIGATOR
References: