Safety of intravenously applied mistletoe extract — results from a phase I dose escalation study in patients with advanced cancer

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dc.contributor.authorHuber, Roman
dc.contributor.authorSchlodder, Dietrich
dc.contributor.authorEffertz, Carola
dc.contributor.authorRieger, Sabine
dc.contributor.authorTröger, Wilfried
dc.date.accessioned2024-05-23T18:53:48Z
dc.date.available2024-05-23T18:53:48Z
dc.date.digitized2020-09-09 02:29:17
dc.date.issued2017
dc.description.abstract<strong>Background</strong>: Mistletoe extracts have anti-tumor properties and are approved for subcutaneous use in cancer patients. Data on Intravenous application are limited.<br /><strong>Methods</strong>: An aqueous extract from pine-mistletoe was used to investigate maximum tolerable dose (MTD) and safety of intravenous application. It was infused once weekly for 3 weeks in patients with advanced cancer. Any type of cancer was included; relevant exclusion criteria were concurrent chemo- or radiation therapy. The classical phase I 3 + 3 dose escalation scheme was followed. Predefined dose groups were 200, 400, 700, 1200 and 2000 mg.<br />Maximum planned dose was 2000 mg. With the MTD three more patients should be treated for 9 weeks in order to evaluate intermediate term tolerability. Weekly during the treatment and 1 week later tolerability, clinical status, safety laboratory parameters and adverse events were documented.<br /><strong>Results</strong>: Twenty-one patients (3 in the dose groups 200, 400, 700 and 1200 mg, respectively, 9 in the dose group 2000 mg) were included. MTD was not reached. Because one dose-limiting toxicity (DLT), an allergic reaction, occurred during infusion of 2000 mg, three more patients had to be included in this dose group and tolerated it, as well as the three patients who received 2000 mg for 9 weeks. Occasionally in the dose group 2000 mg mild to moderate fever occurred. Conclusion: Weekly infusions of 2000 mg of the pine-mistletoe extract were tolerated and can be used in further studies but had a risk for allergic reactions and fever. German Clinical Trials Register (Trial registration number DRKS00005028).<br /><strong>Keywords</strong>: Viscum album, Intravenous, Cancer, Clinical trial, MTD, Side effects </p> <p><strong>Citation</strong>: Huber, R., Schlodder, D., Effertz, C., Rieger, S., &amp; Tröger, W. (2017). Safety of intravenously applied mistletoe extract – results from a phase I dose escalation study in patients with advanced cancer. <em>BMC Complementary and Alternative Medicine</em>, <em>17</em>(1), 465. <a href="https://doi.org/10.1186/s12906-017-1971-1" target="_blank">https://doi.org/10.1186/s12906-017-1971-1</a></p>
dc.description.notesfixed
dc.identifier.citationHuber, R., Schlodder, D., Effertz, C., Rieger, S., & Tröger, W. (2017). Safety of intravenously applied mistletoe extract – results from a phase I dose escalation study in patients with advanced cancer. BMC Complementary and Alternative Medicine, 17(1), 465. https://doi.org/10.1186/s12906-017-1971-1
dc.identifier.doihttps://doi.org/10.1186/s12906-017-1971-1
dc.identifier.externalUrl/library/2020/8/13/safety-of-intravenously-applied-mistletoe-extract-results-from-a-phase-i-dose-escalation-study-in-patients-with-advanced-cancer
dc.identifier.urihttps://hdl.handle.net/20.500.14430/409
dc.subject.otherIntravenous Mistletoe Therapy Safety
dc.subject.otherDose Escalation Study
dc.subject.otherViscum album
dc.subject.otherIntravenous
dc.subject.otherMTD
dc.subject.otherSide effects
dc.subject.otherCancer
dc.subject.otherClinical trials
dc.titleSafety of intravenously applied mistletoe extract — results from a phase I dose escalation study in patients with advanced cancer
dspace.entity.typePublication
oaire.citation.titleBMC Comp & Alt Med
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