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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hiscia Society for Cancer Research
IFAG Basel AG, both Switzerland
Information provided by (Responsible Party):
IFAG AG
ClinicalTrials.gov Identifier:
NCT01448668
First received: March 30, 2011
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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
Pancreas Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by IFAG AG:

Primary Outcome Measures:
  • Overall survival time (OS). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 220
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)
Groups/Cohorts
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).

Detailed Description:

see summary

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448668

Locations
Austria
5th Med., Clinic Hietzing
Vienna, Austria
University Vienna
Vienna, Austria
Germany
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
IFAG AG
Hiscia Society for Cancer Research
IFAG Basel AG, both Switzerland
Investigators
Principal Investigator: Volker Heinemann, Prof. MD Med. Clinic III, University Clinic Munich Grosshadern
  More Information

No publications provided

Responsible Party: IFAG AG
ClinicalTrials.gov Identifier: NCT01448668     History of Changes
Other Study ID Numbers: ISC-4.1.6, 2010-018683-17
Study First Received: March 30, 2011
Last Updated: July 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by IFAG AG:
pancreatic cancer
mistletoe
supportive treatment
long-term study
non-interventional cohort study
controlled study with parallel groups

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Viscum album peptide
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014