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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01448668

Enrollment

220

Registered

2011-10-07

Start date

2010-09-30

Completion date

2016-06-30

Last updated

2013-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer

Keywords

pancreatic cancer, mistletoe, supportive treatment, long-term study, non-interventional cohort study, controlled study with parallel groups

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.

Detailed description

see summary

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survival time (OS).	3 years

Secondary

Measure	Time frame	Description
Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)	1 year	As key symptom, the fatigue syndrome will be evaluated separately.
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	—

Countries

Austria, Germany

Outcome results