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.
see summary
Study Type
OBSERVATIONAL
Enrollment
300
5th Med., Clinic Hietzing
Vienna, Austria
RECRUITINGUniversity Vienna
Vienna, Austria
RECRUITINGAugusta Clinic
Bochum, Germany
RECRUITINGMVZ Fulda
Fulda, Germany
RECRUITINGUniversity Clinic - Internal Medicine I
Halle, Germany
RECRUITINGHospital Herdecke, private University
Herdecke, Germany
RECRUITINGMed. Clinic III, University Munich, Grosshadern
Munich, Germany
RECRUITINGClinic Kloster Paradiese
Soest, Germany
RECRUITINGMed 1, University Clinic Ulm
Ulm, Germany
RECRUITINGDisease-free survival time (DFS).
Time frame: 5 years
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.
Time frame: 1 year
Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score
Time frame: 1 year
Interim analysis on overall survival time (OS) in UICC stage IV patients
Time frame: 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
Time frame: 5 years
Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).
Time frame: 1 year
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