Mistletoe Extract in Early or Advanced Breast Cancer, A F... | NCT00176046

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

NCT00176046

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

May 8, 2017Actual

Enrollment

114Actual

Phase

Phase 4

Conditions

Metastatic Breast Cancer

Interventions

viscum album pini
viscum album pini

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1999Actual

Primary Completion Date

Jun 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Sep 10, 2005

First Submission Date that Met QC Criteria

Sep 10, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2017

Last Update Posted Date

May 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cornelia von Hagens, Head Complementary & Integrative Medicine, Dep. 4.2, Heidelberg UniversityPrincipal Investigator

Lead Sponsor

Heidelberg UniversityOTHER

Collaborators

Name	Class
Verein für Krebsforschung, Arlesheim, Swizzerland	UNKNOWN
Weleda AG, D-73525 Schwäbisch Gmünd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
viscum album pini	Drug	s.c. injection of 0,001-20 mg 3 times per week	viscum album pini

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
local reactions		6-30 months
documentation of concomitant medication		6-30 months
documentation of concomitant therapies

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cornelia U. von Hagens, MD	Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Complementary and Integrative Medicine		Heidelberg	Baden-Wurttemberg	D-69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided