Clinical trial · Interventional
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
NCT02948309CI-TRIAL-00063204MISTRALcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mistletoe extract (Iscador Qu) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mistletoe extract (Iscador Qu)
- description
- Fermented aqueous extract of Viscum album ssp album (L.) (mistletoe) = Iscador Qu, subcutaneous use 3 injections/week; dose escalation from 0,01mg - 20mg
- interventionNames
- Drug: Mistletoe extract (Iscador Qu)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- isotonic saline solution, subcutaneous use 3 injections/week
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- End of study (estimated 3 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (7)
- BACKGROUNDTroger 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. PMID 25142075
- BACKGROUNDTroger 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. PMID 23890767
- BACKGROUNDHorneber 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. PMID 18425885
- BACKGROUNDKienle 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. PMID 19519890
- DERIVEDWode 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. PMID 42059487
- DERIVEDWode 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. PMID 38915151