Clinical trial NCT01448655: Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: colorectal cancer
mistletoe
supportive treatment
long-term study
non-interventional cohort study
controlled study with parallel groups
Lead sponsor: IFAG AG
Sponsor class: INDUSTRY
Collaborators: name: Hiscia Society for Cancer Research
name: IFAG Basel AG (CRO), both Switzerland
First posted: 2011-10-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: see summary

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival time (DFS).
timeFrame: 5 years
Secondary outcomes:
measure: Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)
timeFrame: 1 year
measure: Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score
timeFrame: 1 year
measure: Interim analysis on overall survival time (OS) in UICC stage IV patients
timeFrame: 2 years
measure: Safety of Iscador® Qu (number of patients with systemic or local adverse events (AE) to Iscador® Qu)
timeFrame: 5 years
measure: Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: 5th Med., Clinic Hietzing
city: Vienna
country: Austria
facility: University Vienna
city: Bochum
country: Germany
facility: Augusta Clinic
city: Fulda
country: Germany
facility: MVZ Fulda
city: Halle (Saale)
country: Germany
facility: University Clinic - Internal Medicine I
city: Herdecke
country: Germany
facility: Hospital Herdecke, private University
city: Munich
country: Germany
facility: Med. Clinic III, University Munich, Grosshadern
city: Soest
country: Germany
facility: Clinic Kloster Paradiese
city: Ulm
country: Germany
facility: Med 1, University Clinic Ulm
Study officials:
affiliation: University Clinic Halle (Saale)
name: Thomas Seufferlein, Prof. M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.