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Pancreatic CancerPhase 3MISTRALNCT02948309

Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer

A Phase 3 study testing Mistletoe extract (Iscador Qu) in people with Pancreatic Cancer, run by Karolinska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Mistletoe extract (Iscador Qu)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
290 participants
Where
1 siteSweden
Study dates
Jun 2016to Sep 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Kathrin Wode

    Stockholm, 14186

Other trials in Sweden

About this study

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

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.

Read the 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. 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).

Being tested
Mistletoe extract (Iscador Qu), Placebo
Keywords
Primary diagnosis, Relapse
Medical subject headings
Pancreatic Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mistletoe extract (Iscador Qu)Drug

    Also called Fermented aqueous extract of Viscum album ssp album (L.)

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

  • PlaceboDrug

    Also called Isotonic saline solution

    1ml subcutaneous injection 3 times/week

Study groups in NCT02948309
Study groupRoleWhat they receive
Mistletoe extract (Iscador Qu)ExperimentalFermented aqueous extract of Viscum album ssp album (L.) (mistletoe) = Iscador Qu, subcutaneous use 3 injections/week; dose escalation from 0,01mg - 20mg
Receives: Drug: Mistletoe extract (Iscador Qu)
PlaceboPlacebo comparatorisotonic saline solution, subcutaneous use 3 injections/week
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    OS defined as time from randomization to death for any reason

    Measured: End of study (estimated 3 years)

Secondary outcomes (11)

  1. Quality of Life questionnaire EORTC QLQ-C30

    Evaluation according to EORTC QLQ-C30 Scoring Manual

    Measured: At 7 visits during study (9 months)

  2. Quality of Life questionnaire EORTC PAN -26

    Evaluation according to EORTC PAN-26 Scoring Manual

    Measured: At 7 visits during study (9 months)

  3. Weight in kilograms, height in meters, BMI in kg/m^2

    Body weight, Body Mass Index

    Measured: At 7 visits during study (9 months)

  4. Corticosteroid use in milligrams betamethasone per day and indication (appetite, chemotherapy, nausea, pain, general wellbeing, other: specified)

    Corticosteroid use and indication

    Measured: At 7 visits during study (9 months)

  5. Number of visits of homecare team per week

    Costs for supportive care

    Measured: At 7 visits during study (9 months)

  6. Use of oral nutrition support per week (number used per day)

    Costs for supportive care

    Measured: At 7 visits during study (9 months)

  7. Use of symptom relieving medication in mg/day (painkillers, antiemetic and anxiolitic medication)

    Costs for supportive care

    Measured: At 7 visits during study (9 months)

  8. Chemotherapy use (number of cycles first line, second line, ..) and dose reduction in%

    Costs for supportive care

    Measured: At 7 visits during study (9 months)

  9. Number of parenteral nutrition infusions per week

    Costs for supportive care

    Measured: At 7 visits during study (9 months)

  10. Days of unplanned inpatient care

    Costs for inpatient care

    Measured: At 7 visits during study (9 months)

  11. Incidence of treatment-emergent adverse events (AE)

    Safety

    Measured: Through study completion (9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionSep 2022
  4. Study completionSep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02948309
Sponsor's protocol ID
131016
Other IDs
2014-004552-64, 2014
Acronym
MISTRAL
Status last verified
Jan 2023
First submitted
13 Sep 2016
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: The trial results will be submitted for publication in relevant medical journals

Publications

  • Troger W, Galun D, Reif M, Schumann A, Stankovic N, Milicevic M. Quality of life of patients with advanced pancreatic cancer during treatment with mistletoe: a randomized controlled trial. Dtsch Arztebl Int. 2014 Jul 21;111(29-30):493-502, 33 p following 502. doi: 10.3238/arztebl.2014.0493.

    PubMed 25142075

  • Troger W, Galun D, Reif M, Schumann A, Stankovic N, Milicevic M. Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: a randomised clinical trial on overall survival. Eur J Cancer. 2013 Dec;49(18):3788-97. doi: 10.1016/j.ejca.2013.06.043. Epub 2013 Jul 24.

    PubMed 23890767

  • Horneber MA, Bueschel G, Huber R, Linde K, Rostock M. Mistletoe therapy in oncology. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD003297. doi: 10.1002/14651858.CD003297.pub2.

    PubMed 18425885

  • Kienle GS, Glockmann A, Schink M, Kiene H. Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research. J Exp Clin Cancer Res. 2009 Jun 11;28(1):79. doi: 10.1186/1756-9966-28-79.

    PubMed 19519890

  • Wode K, Bjor O, Klein R, Elander NO, Fransson P, Henriksson R, Sharp L, Scheibling U, Johansson B, Hok Nordberg J, Kienle GS. Mistletoe extract in patients with advanced pancreatic cancer: Health-related quality of life in a double-blind, randomized, placebo-controlled trial (MISTRAL). Palliat Med. 2026 Jul;40(7):1059-1076. doi: 10.1177/02692163261437609. Epub 2026 Apr 30.

    PubMed 42059487

  • Wode K, Kienle GS, Bjor O, Fransson P, Sharp L, Elander NO, Bernhardson BM, Johansson B, Edwinsdotter Ardnor C, Scheibling U, Hok Nordberg J, Henriksson R. Mistletoe Extract in Patients With Advanced Pancreatic Cancer: a Double-Blind, Randomized, Placebo-Controlled Tial (MISTRAL). Dtsch Arztebl Int. 2024 May 31;121(11):347-354. doi: 10.3238/arztebl.m2024.0080.

    PubMed 38915151

  • Wode K, Hok Nordberg J, Kienle GS, Elander NO, Bernhardson BM, Sunde B, Sharp L, Henriksson R, Fransson P. Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL). Trials. 2020 Sep 11;21(1):783. doi: 10.1186/s13063-020-04581-y.

    PubMed 32917288

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mistletoe extract (Iscador Qu) in people with Pancreatic Cancer, run by Karolinska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: End of study (estimated 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02948309, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.

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