Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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 Pancreatic Cancer Stages UICC II-IV|
- Overall survival time (OS). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life) [ Time Frame: 1 year ] [ Designated as safety issue: No ]As key symptom, the fatigue syndrome will be evaluated separately.
- Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Safety of Iscador® Qu (number of patients with systemic or local AE to Iscador® Qu) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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).
The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).
|5th Med., Clinic Hietzing|
|University Clinic - Internal Med. I|
|Halle (Saale), Germany|
|Med. Clinic III, University Munich Grosshadern|
|Clinic Kloster Paradiese|
|University Clinic Ulm|
|Principal Investigator:||Volker Heinemann, Prof. MD||Med. Clinic III, University Clinic Munich Grosshadern|