NCT01448655

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
2 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

6.3 years

First QC Date

March 29, 2011

Last Update Submit

July 1, 2013

Conditions

Colorectal Cancer

Keywords

colorectal cancermistletoesupportive treatmentlong-term studynon-interventional cohort studycontrolled study with parallel groups

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival time (DFS).

    5 years

Secondary Outcomes (5)

  • Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)

    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)

    5 years

  • Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).

    1 year

Study Arms (2)

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).

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

5th Med., Clinic Hietzing

Vienna, Austria

RECRUITING

University Vienna

Vienna, Austria

RECRUITING

Augusta Clinic

Bochum, Germany

RECRUITING

MVZ Fulda

Fulda, Germany

RECRUITING

University Clinic - Internal Medicine I

Halle, 06120, Germany

RECRUITING

Hospital Herdecke, private University

Herdecke, Germany

RECRUITING

Med. Clinic III, University Munich, Grosshadern

Munich, Germany

RECRUITING

Clinic Kloster Paradiese

Soest, Germany

RECRUITING

Med 1, University Clinic Ulm

Ulm, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20021637BACKGROUND

  • 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.

    PMID: 19883529BACKGROUND

  • 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.

    PMID: 18955241BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Thomas Seufferlein, Prof. M.D.

    University Clinic Halle (Saale)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard M Stauder, PhD

CONTACT

+49 (8171) 96269stauder@ifag.biz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2011

First Posted

October 7, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

AU(2)DE(7)