Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)

Colorectal Cancer Clinical Trial

Official title:

Prospective Epidemiological Study to Expand Knowledge on Efficacy and Safety of a Routine Post-operative Supportive Therapy With the Mistletoe Extract Iscador® Qu Within Oncological Treatment of Colorectal Cancer Stages UICC II-IV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01448655
• Other study ID #: ISC-4.1.5
• Secondary ID: 2010-018682-31
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2011
• Last updated: July 1, 2013
• Start date: September 2010
• Est. completion date: June 2017

Study information

• Verified date: July 2013
• Source: IFAG AG
• Contact: Gerhard M Stauder, PhD
• Phone: +49 (8171) 96269
• Email: stauder[@]ifag.biz
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with colorectal cancer (Union for International Cancer Control, UICC stages II-IV), in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.

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.

Description:

see summary

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of colorectal cancer, UICC stage II-IV

• 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:

• Anal cancer

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Austria	5th Med., Clinic Hietzing	Vienna
Austria	University Vienna	Vienna
Germany	Augusta Clinic	Bochum
Germany	MVZ Fulda	Fulda
Germany	University Clinic - Internal Medicine I	Halle (Saale)
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

Sponsors (3)

Lead Sponsor	Collaborator
IFAG AG	Hiscia Society for Cancer Research, IFAG Basel AG (CRO), both Switzerland

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (3)

Friedel WE, Matthes H, Bock PR, Zänker 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. — View Citation

Ostermann T, Raak C, Büssing 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival time (DFS).		5 years	No
Secondary	Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)	As key symptom, the fatigue syndrome will be evaluated separately.	1 year	No
Secondary	Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score		1 year	No
Secondary	Interim analysis on overall survival time (OS) in UICC stage IV patients		2 years	No
Secondary	Safety of Iscador® Qu (number of patients with systemic or local adverse events (AE) to Iscador® Qu)	Adverse events (local and/or systemic) contributable to Iscador® Qu	5 years	Yes
Secondary	Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).		1 year	No