Home > Publications Database > Results of the preclinical multicenter randomized controlled paclitaxel-induced neuropathy prevention replication study (PINPRICS). > print

001     277974
005     20250430100240.0
024 7 _ |a 10.1186/s13104-025-07206-2
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037 _ _ |a DZNE-2025-00506
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082 _ _ |a 570
100 1 _ |a Boehmerle, Wolfgang
|b 0
245 _ _ |a Results of the preclinical multicenter randomized controlled paclitaxel-induced neuropathy prevention replication study (PINPRICS).
260 _ _ |a London
|c 2025
|b [Verlag nicht ermittelbar]
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520 _ _ |a Chemotherapy-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.
536 _ _ |a 353 - Clinical and Health Care Research (POF4-353)
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650 _ 7 |a Chemotherapy-induced polyneuropathy
|2 Other
650 _ 7 |a Neuropathic pain
|2 Other
650 _ 7 |a Neuroprotection
|2 Other
650 _ 7 |a Preclinical replication study
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650 _ 7 |a Paclitaxel
|0 P88XT4IS4D
|2 NLM Chemicals
650 _ 7 |a Lithium Carbonate
|0 2BMD2GNA4V
|2 NLM Chemicals
650 _ 7 |a Pyrimidines
|2 NLM Chemicals
650 _ 7 |a nilotinib
|0 F41401512X
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650 _ 7 |a Antibodies, Neutralizing
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650 _ 7 |a Interleukin-6
|2 NLM Chemicals
650 _ 7 |a Antineoplastic Agents, Phytogenic
|2 NLM Chemicals
650 _ 2 |a Paclitaxel: adverse effects
|2 MeSH
650 _ 2 |a Animals
|2 MeSH
650 _ 2 |a Mice
|2 MeSH
650 _ 2 |a Female
|2 MeSH
650 _ 2 |a Lithium Carbonate: pharmacology
|2 MeSH
650 _ 2 |a Lithium Carbonate: therapeutic use
|2 MeSH
650 _ 2 |a Lithium Carbonate: administration & dosage
|2 MeSH
650 _ 2 |a Pyrimidines: therapeutic use
|2 MeSH
650 _ 2 |a Pyrimidines: pharmacology
|2 MeSH
650 _ 2 |a Pyrimidines: administration & dosage
|2 MeSH
650 _ 2 |a Humans
|2 MeSH
650 _ 2 |a Peripheral Nervous System Diseases: chemically induced
|2 MeSH
650 _ 2 |a Peripheral Nervous System Diseases: prevention & control
|2 MeSH
650 _ 2 |a Antibodies, Neutralizing: pharmacology
|2 MeSH
650 _ 2 |a Antibodies, Neutralizing: therapeutic use
|2 MeSH
650 _ 2 |a Interleukin-6: immunology
|2 MeSH
650 _ 2 |a Interleukin-6: antagonists & inhibitors
|2 MeSH
650 _ 2 |a Antineoplastic Agents, Phytogenic: adverse effects
|2 MeSH
650 _ 2 |a Cell Line, Tumor
|2 MeSH
650 _ 2 |a Xenograft Model Antitumor Assays
|2 MeSH
650 _ 2 |a Breast Neoplasms: drug therapy
|2 MeSH
650 _ 2 |a Breast Neoplasms: pathology
|2 MeSH
700 1 _ |a Hagenacker, Tim
|b 1
700 1 _ |a Leo, Markus
|b 2
700 1 _ |a Schmitt, Linda-Isabell
|b 3
700 1 _ |a Lehmann, Helmar C
|b 4
700 1 _ |a Klein, Ines
|b 5
700 1 _ |a Stegherr, Regina
|b 6
700 1 _ |a Konietschke, Frank
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700 1 _ |a Endres, Matthias
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700 1 _ |a Huehnchen, Petra
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773 _ _ |a 10.1186/s13104-025-07206-2
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