Neoplasms

Blood and Lymph Conditions

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Antineoplastic Agents

All Drugs and Chemicals

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Adramycin

Procarbacine

Erythropoietin beta

Andreas Josting, Dr.

This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.

Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma

University of Cologne

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Recurrence

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

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Quality of Life

Pharmaceutical Solutions

Herbal and Botanical

Viscum album peptide

Anti-HIV Agents

Anti-Retroviral Agents

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European Mistletoe

Fermented aqueous extract of Viscum album ssp album (L.) (mistletoe) = Iscador Qu, subcutaneous use 3 injections/week; dose escalation from 0,01mg - 20mg

isotonic saline solution, subcutaneous use 3 injections/week

1ml subcutaneous injection 3 times/week, dose escalation 0,01mg - 20mg

Mistletoe extract (Iscador Qu)

Placebo

Annika Bergquist, Ass Prof

In this study a mistletoe preparation (Iscador Qu) is added to standard therapy in inoperable pancreatic cancer in order to evaluate effect on overall survival and health-related quality of life. Half of participants will take subcutaneous injections with mistletoe in addition to standard therapy (palliative chemotherapy or best supportive care); the other half will receive a placebo and standard therapy.

Extracts from European mistletoe (Viscum album L.) have been used as complementary cancer therapy since the 1920s. To date over 160 clinical studies on mistletoe in cancer therapy have been conducted with varying quality; the therapy is still controversial.

Best evidence is found for increase of health-related quality of life (HRQoL) and reduction of side effects of conventional therapies (chemotherapy, radiation) in breast cancer patients. Mistletoe treatment is described as safe and well tolerated. There are some clinical studies supporting the use of mistletoe extract in the management of late stage cancer.

Statistically significant effects on overall survival (OS) and HRQoL in pancreatic cancer patients have recently been shown in a randomized open label trial in Serbia investigating the addition of mistletoe extract to best supportive care. The results are questioned because patients knew what kind of treatment they received.

Mistletoe extracts are usually administered subcutaneously. They contain a multitude of substances with immune modulatory and cytotoxic or - in animal studies - antitumorigenic, anti-metastatic and antiangiogenic effects.

This trial investigates whether there is a beneficial effect of mistletoe extracts on OS and HRQoL in pancreatic cancer patients receiving standard treatment (palliative chemotherapy or best supportive care).

Inclusion has started at 4 study centers (2 more centers are waiting for participation). And participants are randomized 1:1 to mistletoe treatment (Iscador Qu®) given in increasing dosage from 0,01mg to 20 mg or placebo injections subcutaneously 3 times /week. Stratification will be performed for received oncological treatment (palliative chemotherapy or best supportive care). At 7 visits in 9 months, participants fill in the validated EORTC QLQ-C30 (QLO=quality of life questionnaire) and PAN-26 (PAN=pancreas) quality of life questionnaires. Body weight, use of cancer-related medicines, substitution of nutrition, adverse events need of supportive care and inpatient care are measured. To be able to assess more dimensions of quality of life than possible with questionnaires, a qualitative sub-study with interviews on about 30 participants in this trial is performed in month 3. A 2nd substudy has been added november 2016 to elucidate the systemic effects of mistletoe therapy and to explore potential prognostic and predictive biomarkers (anticipated n=100).

Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer

Mistletoe Therapy in Primary & Recurrent Inoperable Pancreatic Cancer. A Phase III Prospective Randomized Double Blinded Multicenter Parallel Group Placebo Controlled Clinical Trial on Overall Survival and Quality of Life

The trial results will be submitted for publication in relevant medical journals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma	NCT00284271	Hodgkin´s Lymph...	Cyclophosphamid... Adramycin Procarbacine Prednisone Vincristine Bleomycin Erythropoietin ...	61 Years - 75 Years	University of Cologne
Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer	NCT02948309	Pancreatic Canc...	Mistletoe extra... Placebo	18 Years -	Karolinska University Hospital
Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma	NCT00284271	Hodgkin´s Lymph...	Cyclophosphamid... Adramycin Procarbacine Prednisone Vincristine Bleomycin Erythropoietin ...	61 Years - 75 Years	University of Cologne

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