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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448668
Recruitment Status : Unknown
Verified July 2013 by IFAG AG.
Recruitment status was:  Active, not recruiting
First Posted : October 7, 2011
Last Update Posted : July 2, 2013
Hiscia Society for Cancer Research
IFAG Basel AG, both Switzerland
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease
Pancreas Cancer

Detailed Description:
see summary

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Study Type : Observational
Actual Enrollment : 220 participants
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
Study Start Date : September 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

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).

Primary Outcome Measures :
  1. Overall survival time (OS). [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life) [ Time Frame: 1 year ]
    As key symptom, the fatigue syndrome will be evaluated separately.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01448668

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5th Med., Clinic Hietzing
Vienna, Austria
University Vienna
Vienna, Austria
Augusta Clinic
Bochum, Germany
MVZ Fulda
Fulda, Germany
University Clinic - Internal Med. I
Halle (Saale), Germany
Hospital Herdecke
Herdecke, Germany
Med. Clinic III, University Munich Grosshadern
Munich, Germany
Clinic Kloster Paradiese
Soest, Germany
University Clinic Ulm
Ulm, Germany
Sponsors and Collaborators
Hiscia Society for Cancer Research
IFAG Basel AG, both Switzerland
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Principal Investigator: Volker Heinemann, Prof. MD Med. Clinic III, University Clinic Munich Grosshadern

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Responsible Party: IFAG AG Identifier: NCT01448668     History of Changes
Other Study ID Numbers: ISC-4.1.6
2010-018683-17 ( EudraCT Number )
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013
Keywords provided by IFAG AG:
pancreatic cancer
supportive treatment
long-term study
non-interventional cohort study
controlled study with parallel groups
Additional relevant MeSH terms:
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Viscum album peptide
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents