Colorectal Cancer
Conditions
Keywords
colorectal cancer, mistletoe, supportive treatment, long-term study, non-interventional cohort study, controlled study with parallel groups
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
Interventions
None listed
Sponsors
Hiscia Society for Cancer Research
IFAG Basel AG (CRO), both Switzerland
IFAG AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival time (DFS). | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life) | 1 year | As key symptom, the fatigue syndrome will be evaluated separately. |
| 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 | Adverse events (local and/or systemic) contributable to Iscador® Qu |
| Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy). | 1 year | — |
Countries
Austria, Germany
Contacts
Primary ContactGerhard M Stauder, PhD
Outcome results
None listed