Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)

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

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 Overview

• Status: Unknown
• Conditions: Pancreas Cancer

Detailed Description

see summary

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • 5th Med., Clinic Hietzing
  • Vienna, Austria
    • University Vienna
• Germany
  • Bochum, Germany
    • Augusta Clinic
  • Fulda, Germany
    • MVZ Fulda
  • Halle (Saale), Germany
    • University Clinic - Internal Med. I
  • Herdecke, Germany
    • Hospital Herdecke
  • Munich, Germany
    • Med. Clinic III, University Munich Grosshadern
  • Soest, Germany
    • Clinic Kloster Paradiese
  • Ulm, Germany
    • University Clinic Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients visiting the center with pancreatic cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.

Description

Inclusion Criteria:

• Confirmed diagnosis of pancreatic cancer, adenocarcinoma, UICC stage II-IV
• Age between 18 (Austria: 19) and 85 years
• No previous malign tumor
• ECOG 0-2
• Estimated life expectancy > 3 months
• Surgical resection of the tumor (R0, R1) or determination of interoperability
• 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:

• 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
• 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)
• Patients participating in another clinical study with non-approved substances

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).
Control group; The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival time (OS).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score		1 year
Safety of Iscador® Qu (number of patients with systemic or local AE to Iscador® Qu)		3 years
Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).		1 year

Collaborators and Investigators

• Sponsor: IFAG AG
• Collaborators: Hiscia Society for Cancer Research; IFAG Basel AG, both Switzerland
• Investigators: Principal Investigator: Volker Heinemann, Prof. MD, Med. Clinic III, University Clinic Munich Grosshadern

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): July 2, 2013
• Last Update Submitted That Met QC Criteria: July 1, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: pancreatic cancer; mistletoe; supportive treatment; long-term study; non-interventional cohort study; controlled study with parallel groups
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: ISC-4.1.6; 2010-018683-17 (EudraCT Number)