Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer
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.
Timeline
- Start
- 2016-06
- Primary completion
- 2022-09
- Completion
- 2022-09
Outcome
Missed primary endpoint
paper The adjusted hazard ratio for OS was 1.13 [0.89; 1.44], with a median survival time of 7.8 and 8.3 months for ME and placebo, respectively. PMID 38915151 ↗
paper No statistically significant benefit of adding ME to standard treatment was seen with respect to either OS or global health/ QoL. PMID 38915151 ↗
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- 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 Apr 30:2692163261437609. doi: 10.1177/02692163261437609. Online ahead of print.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iscador Qu | Unknown | 20 mg | Subcutaneous |