Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)
NCT ID: NCT01448655
Last Updated: 2013-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2010-09-30
2017-06-30
Brief Summary
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Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 5 years.
Prospective observational confirmation study of previous retrospective cohort study.
As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Test group with Iscador® Qu
The test group will receive the mistletoe extract Iscador® Qu as supportive treatment in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).
No interventions assigned to this group
Control group
The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age between 18 (Austria: 19) and 85 years
* No previous malign tumor
* Surgical resection of the tumor if indicated
* (Post-operative) conventional oncological therapy and measurements, or passive after-care ("best care")
* Follow-up for several years feasible
* Patient gives written consent to use the anonymized date for evaluation
Exclusion Criteria
* Other Iscador® sorts than Qu in the test group
* Other mistletoe preparations in the test group
* Any mistletoe preparation in the control group
* Non-oncological immunomodulating, -stimulating or -suppressive drugs (e.g. Echinacea, interferons, Polyerga®, BCG, azathioprine). Allowed are approved tumor inhibiting immuno- or targeted therapies (e.g. bevacizumab, cetuximab) and tumor specific vaccines
* HIV infection, Aids, organ transplantation
* High-dose systemic glucocorticoids
* Contraindications for Iscador® Qu (allergy against mistletoe, acute inflammatory disease or fever \> 38.5°C, active tuberculosis, hyperthyreosis with not-adjusted metabolism, primary brain or spinal tumor, brain metastases)
* Known mistletoe intolerance
* Patients participating in another clinical study with non-approved substances
18 Years
85 Years
ALL
No
Sponsors
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Hiscia Society for Cancer Research
UNKNOWN
IFAG Basel AG (CRO), both Switzerland
UNKNOWN
IFAG AG
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Seufferlein, Prof. M.D.
Role: PRINCIPAL_INVESTIGATOR
University Clinic Halle (Saale)
Locations
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5th Med., Clinic Hietzing
Vienna, , Austria
University Vienna
Vienna, , Austria
Augusta Clinic
Bochum, , Germany
MVZ Fulda
Fulda, , Germany
University Clinic - Internal Medicine I
Halle, , Germany
Hospital Herdecke, private University
Herdecke, , Germany
Med. Clinic III, University Munich, Grosshadern
Munich, , Germany
Clinic Kloster Paradiese
Soest, , Germany
Med 1, University Clinic Ulm
Ulm, , Germany
Countries
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Central Contacts
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Facility Contacts
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Thomas Stein, MD
Role: primary
Leo Auerbach, Prof. MD
Role: primary
Dirk Behringer, Prof. MD
Role: primary
Andrea Distelrath, MD
Role: primary
Thomas Seufferlein, Prof. M.D.
Role: primary
Florian Glaser, MD
Role: primary
Volker Heinemann, Prof. MD
Role: primary
Eckhard Böcher, Prof. MD
Role: primary
Götz PL von Wichert, MD
Role: primary
References
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Ostermann T, Raak C, Bussing A. Survival of cancer patients treated with mistletoe extract (Iscador): a systematic literature review. BMC Cancer. 2009 Dec 18;9:451. doi: 10.1186/1471-2407-9-451.
Friedel WE, Matthes H, Bock PR, Zanker KS. Systematic evaluation of the clinical effects of supportive mistletoe treatment within chemo- and/or radiotherapy protocols and long-term mistletoe application in nonmetastatic colorectal carcinoma: multicenter, controlled, observational cohort study. J Soc Integr Oncol. 2009 Fall;7(4):137-45.
Ziegler R. Mistletoe Preparation Iscador: Are there Methodological Concerns with Respect to Controlled Clinical Trials? Evid Based Complement Alternat Med. 2009 Mar;6(1):19-30. doi: 10.1093/ecam/nem121. Epub 2007 Oct 4.
Other Identifiers
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2010-018682-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISC-4.1.5
Identifier Type: -
Identifier Source: org_study_id
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