Metastatic Breast CancerPhase 4NCT00176046
Mistletoe Extract in Early or Advanced Breast Cancer, A Feasibility Study
A Phase 4 study testing viscum album pini in people with Metastatic Breast Cancer, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- viscum album pini
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- May 1999to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer
- desire for additional therapy with mistletoe extracts
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Wurttemberg, D-69120
About this 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
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.
Read the 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
- Being tested
- viscum album pini
- Keywords
- breast cancer, mistletoe, complementary therapy, quality of life, immune function, breast cancer (UICC stage I/II)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
viscum album piniDrug
Also called Iscador P serie 0, 1, 2
s.c. injection of 0,001-20 mg 3 times per week
viscum album piniDrug
Also called Iscador P Serie 0, 1, 2
s.c. injection 0,001-20 mg 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| viscum album pini | Experimental | immediate start of treatment with Iscador P s.c. Receives: Drug: viscum album pini |
| waiting group | Active comparator | identical treatment with Iscador P s.c. after waiting period of 3 months Receives: Drug: viscum album pini |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood count
Measured: 6-30 months
lymphocytes
Measured: 6-30 months
lymphocyte stimulation
Measured: 4 months
quality of life
Measured: 6-30 months
anxiety and depression
Measured: 6-30 months
diurnal profile of cortisol
Measured: 6-30 months
expression of zeta-chains on T- and NK-cells
Measured: 6-30 months
Secondary outcomes (3)
local reactions
Measured: 6-30 months
documentation of concomitant medication
Measured: 6-30 months
documentation of concomitant therapies
Measured: 6-30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 1999
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Verein für Krebsforschung, Arlesheim, Swizzerland, Weleda AG, D-73525 Schwäbisch Gmünd
- Responsible party
- Principal investigator, Cornelia von Hagens, Heidelberg University
- Investigators
- Cornelia U. von Hagens, MD, Principal investigator, Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176046
- Sponsor's protocol ID
- WD 40
- Status last verified
- Jun 2009
- First submitted
- 10 Sep 2005
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00176046
- Acronym / sponsor ID
- WD 40
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, mistletoe, complementary therapy, quality of life, immune function, breast cancer (UICC stage I/II)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Verein für Krebsforschung, Arlesheim, Swizzerland, Weleda AG, D-73525 Schwäbisch Gmünd
- Study start
- May 1999 (actual)
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| viscum album pini | Experimental | Drug: viscum album piniimmediate start of treatment with Iscador P s.c. |
| waiting group | Active comparator | Drug: viscum album piniidentical treatment with Iscador P s.c. after waiting period of 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- breast cancer
- desire for additional therapy with mistletoe extracts
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| viscum album piniAlso: Iscador P serie 0, 1, 2s.c. injection of 0,001-20 mg 3 times per week | Drug | viscum album pini |
| viscum album piniAlso: Iscador P Serie 0, 1, 2s.c. injection 0,001-20 mg 3 times per week | Drug | waiting group |
Primary outcome
blood count
Time frame: 6-30 months
lymphocytes
Time frame: 6-30 months
lymphocyte stimulation
Time frame: 4 months
quality of life
Time frame: 6-30 months
anxiety and depression
Time frame: 6-30 months
diurnal profile of cortisol
Time frame: 6-30 months
expression of zeta-chains on T- and NK-cells
Time frame: 6-30 months
3 secondary outcomes
local reactions
Time frame: 6-30 months
documentation of concomitant medication
Time frame: 6-30 months
documentation of concomitant therapies
Time frame: 6-30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia U. von Hagens, MD principal investigator
Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing viscum album pini in people with Metastatic Breast Cancer, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood count (time frame: 6-30 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.