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Trial record 1 of 1 for:    MISTRAL | Recruiting, Not yet recruiting, Available Studies | Sweden
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Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer (MISTRAL)

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ClinicalTrials.gov Identifier: NCT02948309
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
University of Witten/Herdecke
Karolinska Institutet
Regional Cancer Centre Stockholm Gotland
Stiftelsen Konung Gustaf V:s Jubileumsfond för cancerforskning
Signe & Ane Gyllenbergs Stiftelse
Ekhagastiftelsen
Dagmar Ferbs Minnesfond
Cancerforskningsfonden i Norrland
Immunpathologisches Labor, University Tübingen, Prof. Dr. med. R. Klein
Information provided by (Responsible Party):
Kathrin Wode, Karolinska University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Mistletoe extract (Iscador Qu) Drug: Placebo Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mistletoe extract (Iscador Qu)
Fermented aqueous extract of Viscum album ssp album (L.) (mistletoe) = Iscador Qu, subcutaneous use 3 injections/week; dose escalation from 0,01mg - 20mg
Drug: Mistletoe extract (Iscador Qu)
1ml subcutaneous injection 3 times/week, dose escalation 0,01mg - 20mg
Other Name: Fermented aqueous extract of Viscum album ssp album (L.)

Placebo Comparator: Placebo
isotonic saline solution, subcutaneous use 3 injections/week
Drug: Placebo
1ml subcutaneous injection 3 times/week
Other Name: Isotonic saline solution




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: End of study (estimated 3 years) ]
    OS defined as time from randomization to death for any reason


Secondary Outcome Measures :
  1. Quality of Life questionnaire EORTC QLQ-C30 [ Time Frame: At 7 visits during study (9 months) ]
    Evaluation according to EORTC QLQ-C30 Scoring Manual

  2. Quality of Life questionnaire EORTC PAN -26 [ Time Frame: At 7 visits during study (9 months) ]
    Evaluation according to EORTC PAN-26 Scoring Manual

  3. Weight in kilograms, height in meters, BMI in kg/m^2 [ Time Frame: At 7 visits during study (9 months) ]
    Body weight, Body Mass Index

  4. Corticosteroid use in milligrams betamethasone per day and indication (appetite, chemotherapy, nausea, pain, general wellbeing, other: specified) [ Time Frame: At 7 visits during study (9 months) ]
    Corticosteroid use and indication

  5. Number of visits of homecare team per week [ Time Frame: At 7 visits during study (9 months) ]
    Costs for supportive care

  6. Use of oral nutrition support per week (number used per day) [ Time Frame: At 7 visits during study (9 months) ]
    Costs for supportive care

  7. Use of symptom relieving medication in mg/day (painkillers, antiemetic and anxiolitic medication) [ Time Frame: At 7 visits during study (9 months) ]
    Costs for supportive care

  8. Chemotherapy use (number of cycles first line, second line, ..) and dose reduction in% [ Time Frame: At 7 visits during study (9 months) ]
    Costs for supportive care

  9. Number of parenteral nutrition infusions per week [ Time Frame: At 7 visits during study (9 months) ]
    Costs for supportive care

  10. Days of unplanned inpatient care [ Time Frame: At 7 visits during study (9 months) ]
    Costs for inpatient care

  11. Incidence of treatment-emergent adverse events (AE) [ Time Frame: Through study completion (9 months) ]
    Safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Signed written informed consent

  • Age ≥ 18 years
  • Inoperable locally advanced or metastatic pancreatic cancer or relapse of pancreatic cancer.

    • Primary diagnosis: if histology is not clinically achievable diagnosis is to be confirmed according to local practice sufficient for diagnosis and choice of therapy (such as CA19-9 (=cancer antigen 19-9) and CT).
    • Relapse: histology (not required) or diagnosis according to local practice such as clinical signs and/or imaging and/or CA19-9.
  • ECOG ( Eastern Cooperative Oncology Group) performance status 0-2 (see table in section 12.14 )
  • Adequate negative pregnancy test and adequate contraception (where appropriate)

Exclusion Criteria:

Life expectancy less than 4 weeks

  • Pregnancy or breastfeeding
  • Neuroendocrine tumors of the pancreas (NET)
  • Current use of interferon, G-CSF (granulocyte colony-stimulating factor) and thymus preparations
  • Symptomatic brain edema due to brain metastases
  • Known hypersensitivity to mistletoe-containing products
  • Current use of mistletoe extract preparations in any form
  • Chronic granulomatous disease or active autoimmune disease or autoimmune disease with immunosuppressive treatment
  • Medical, psychiatric, cognitive or other conditions that may compromise the patient´s ability to understand the patient information, give informed consent, comply with the study protocol or complete the study (e.g. needle phobia).

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 ClinicalTrials.gov identifier (NCT number): NCT02948309


Contacts
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Contact: Kathrin Wode, MD +46 8 585 828 64 kathrin.wode@sll.se
Contact: Roger Henriksson, Prof +46-8 12313827 roger.henriksson@sll.se

Locations
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Sweden
Kathrin Wode Recruiting
Stockholm, Sweden, 14186
Contact: Kathrin Wode, MD    +46-8-12314261;+46-707-374261    kathrin.wode@sll.se   
Contact: Maura Krook, study nurse    08-58582864, 073-9660811    maura.krook@sll.se   
Sponsors and Collaborators
Karolinska University Hospital
University of Witten/Herdecke
Karolinska Institutet
Regional Cancer Centre Stockholm Gotland
Stiftelsen Konung Gustaf V:s Jubileumsfond för cancerforskning
Signe & Ane Gyllenbergs Stiftelse
Ekhagastiftelsen
Dagmar Ferbs Minnesfond
Cancerforskningsfonden i Norrland
Immunpathologisches Labor, University Tübingen, Prof. Dr. med. R. Klein
Investigators
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Study Chair: Annika Bergquist, Ass Prof Gastrocentrum Karolinska University Hospital

Publications:
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Responsible Party: Kathrin Wode, MD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02948309     History of Changes
Other Study ID Numbers: 131016
2014-004552-64 ( EudraCT Number )
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The trial results will be submitted for publication in relevant medical journals

Keywords provided by Kathrin Wode, Karolinska University Hospital:
Primary diagnosis
Relapse

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