An observational study in Pancreas Cancer, sponsored by IFAG AG. Status unknown at 9 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-07-02.
Sponsored by IFAG AG · Observational
Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with pancreatic cancer (Union for International Cancer Control, UICC stages II-IV), in addition to 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 3 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
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 220 is close to the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →IFAG AG is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients visiting the center with pancreatic cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.
Exclusion Criteria:
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).
The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).
Overall survival time (OS).
Time frame: 3 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
Safety of Iscador® Qu (number of patients with systemic or local AE to Iscador® Qu)
Time frame: 3 years
Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).
Time frame: 1 year
This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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