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000277974 1001_ $$aBoehmerle, Wolfgang$$b0
000277974 245__ $$aResults of the preclinical multicenter randomized controlled paclitaxel-induced neuropathy prevention replication study (PINPRICS).
000277974 260__ $$aLondon$$b[Verlag nicht ermittelbar]$$c2025
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000277974 520__ $$aChemotherapy-induced peripheral neuropathy (CIPN) is a frequent and serious side effect of many cytotoxic drugs, including paclitaxel. Despite the identification of treatment options in animal models, clinical trials for the treatment or prevention of CIPN have been negative. Major challenges for successful clinical translation of preclinical data include a lack of reproducibility and randomization, small sample sizes and insufficient statistical tests. We therefore conducted a confirmatory, preclinical multicenter randomized controlled replication trial to test the safety and efficacy of three drugs for preventing paclitaxel-induced polyneuropathy: (1) nilotinib, (2) lithium carbonate and (3) interleukin-6-neutralizing antibodies. We preregistered the data analysis plan as well as the two-step study protocol: the optimal doses of the three compounds were assessed first and then tested in a mouse breast cancer xenograft model to compare safety and efficacy.Unfortunately, toxicity of intraperitoneally administered nilotinib in combination with paclitaxel was observed, and higher-than-expected tumor growth resulted in a lack of power when the trial was analyzed. Thus, although lithium carbonate and IL-6-neutralizing antibodies tended toward neuroprotection, the differences between these groups were not statistically significant. However, the PINPRICS study ultimately still provides important lessons with regard to the planning and conduction of multicenter preclinical trials.
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000277974 650_7 $$2Other$$aChemotherapy-induced polyneuropathy
000277974 650_7 $$2Other$$aNeuropathic pain
000277974 650_7 $$2Other$$aNeuroprotection
000277974 650_7 $$2Other$$aPreclinical replication study
000277974 650_7 $$0P88XT4IS4D$$2NLM Chemicals$$aPaclitaxel
000277974 650_7 $$02BMD2GNA4V$$2NLM Chemicals$$aLithium Carbonate
000277974 650_7 $$2NLM Chemicals$$aPyrimidines
000277974 650_7 $$0F41401512X$$2NLM Chemicals$$anilotinib
000277974 650_7 $$2NLM Chemicals$$aAntibodies, Neutralizing
000277974 650_7 $$2NLM Chemicals$$aInterleukin-6
000277974 650_7 $$2NLM Chemicals$$aAntineoplastic Agents, Phytogenic
000277974 650_2 $$2MeSH$$aPaclitaxel: adverse effects
000277974 650_2 $$2MeSH$$aAnimals
000277974 650_2 $$2MeSH$$aMice
000277974 650_2 $$2MeSH$$aFemale
000277974 650_2 $$2MeSH$$aLithium Carbonate: pharmacology
000277974 650_2 $$2MeSH$$aLithium Carbonate: therapeutic use
000277974 650_2 $$2MeSH$$aLithium Carbonate: administration & dosage
000277974 650_2 $$2MeSH$$aPyrimidines: therapeutic use
000277974 650_2 $$2MeSH$$aPyrimidines: pharmacology
000277974 650_2 $$2MeSH$$aPyrimidines: administration & dosage
000277974 650_2 $$2MeSH$$aHumans
000277974 650_2 $$2MeSH$$aPeripheral Nervous System Diseases: chemically induced
000277974 650_2 $$2MeSH$$aPeripheral Nervous System Diseases: prevention & control
000277974 650_2 $$2MeSH$$aAntibodies, Neutralizing: pharmacology
000277974 650_2 $$2MeSH$$aAntibodies, Neutralizing: therapeutic use
000277974 650_2 $$2MeSH$$aInterleukin-6: immunology
000277974 650_2 $$2MeSH$$aInterleukin-6: antagonists & inhibitors
000277974 650_2 $$2MeSH$$aAntineoplastic Agents, Phytogenic: adverse effects
000277974 650_2 $$2MeSH$$aCell Line, Tumor
000277974 650_2 $$2MeSH$$aXenograft Model Antitumor Assays
000277974 650_2 $$2MeSH$$aBreast Neoplasms: drug therapy
000277974 650_2 $$2MeSH$$aBreast Neoplasms: pathology
000277974 7001_ $$aHagenacker, Tim$$b1
000277974 7001_ $$aLeo, Markus$$b2
000277974 7001_ $$aSchmitt, Linda-Isabell$$b3
000277974 7001_ $$aLehmann, Helmar C$$b4
000277974 7001_ $$aKlein, Ines$$b5
000277974 7001_ $$aStegherr, Regina$$b6
000277974 7001_ $$aKonietschke, Frank$$b7
000277974 7001_ $$0P:(DE-2719)2811033$$aEndres, Matthias$$b8$$eLast author$$udzne
000277974 7001_ $$aHuehnchen, Petra$$b9
000277974 773__ $$0PERI:(DE-600)2413336-X$$a10.1186/s13104-025-07206-2$$gVol. 18, no. 1, p. 145$$n1$$p145$$tBMC Research Notes$$v18$$x1756-0500$$y2025
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