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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer

Detailed Description

see summary

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Gerhard M Stauder, PhD; Phone Number: +49 (8171) 96269; Email: stauder@ifag.biz

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • 5th Med., Clinic Hietzing
    • Contact: Thomas Stein, MD
  • Vienna, Austria
    • Recruiting
    • University Vienna
    • Contact: Leo Auerbach, Prof. MD
• Germany
  • Bochum, Germany
    • Recruiting
    • Augusta Clinic
    • Contact: Dirk Behringer, Prof. MD
  • Fulda, Germany
    • Recruiting
    • MVZ Fulda
    • Contact: Andrea Distelrath, MD
  • Halle (Saale), Germany, 06120
    • Recruiting
    • University Clinic - Internal Medicine I
    • Contact: Thomas Seufferlein, Prof. M.D.
    • Principal Investigator: Thomas Seufferlein, Prof. M.D.
  • Herdecke, Germany
    • Recruiting
    • Hospital Herdecke, private University
    • Contact: Florian Glaser, MD
  • Munich, Germany
    • Recruiting
    • Med. Clinic III, University Munich, Grosshadern
    • Contact: Volker Heinemann, Prof. MD
  • Soest, Germany
    • Recruiting
    • Clinic Kloster Paradiese
    • Contact: Eckhard Böcher, Prof. MD
  • Ulm, Germany
    • Recruiting
    • Med 1, University Clinic Ulm
    • Contact: Götz PL von Wichert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients visiting the center with colorectal cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).
Control group; The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival time (DFS).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score		1 year
Interim analysis on overall survival time (OS) in UICC stage IV patients		2 years
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
Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).		1 year

Collaborators and Investigators

• Sponsor: IFAG AG
• Collaborators: Hiscia Society for Cancer Research; IFAG Basel AG (CRO), both Switzerland
• Investigators: Principal Investigator: Thomas Seufferlein, Prof. M.D., University Clinic Halle (Saale)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): July 2, 2013
• Last Update Submitted That Met QC Criteria: July 1, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: colorectal cancer; mistletoe; supportive treatment; long-term study; non-interventional cohort study; controlled study with parallel groups
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ISC-4.1.5; 2010-018682-31 (EudraCT Number)