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PREPARE, a study funded by SPARK-BIH and the BMBF, is investigating the protective effect of lithium in breast cancer patients
Chemotherapy is often associated with severe neurological side effects. The multicenter study PREPARE led by Charité – Universitätsmedizin Berlin now aims to find out whether preventive lithium administration during chemotherapy can alleviate or even entirely prevent neurological complications in breast cancer patients.
The SPARK-BIH program of Charité BIH Innovation (CBI), the joint technology transfer office of Charité and the Berlin Institute of Health at Charité (BIH), provided extensive support in the preparatory phase of the study and helped secure funding from the BMBF.
An important therapeutic agent in the treatment of breast cancer is the drug paclitaxel, which is derived from the bark of the Pacific yew tree and is highly effective at inhibiting tumor growth. However, some patients experience neurological side effects or even long-term consequences: they suffer from loss of concentration and memory, they develop painful paresthesia in their hands and feet, and their fine motor skills or gait are impaired. Physicians call these side effects “chemotherapy-induced polyneuropathy” (CIPN), and they occur in more than half of breast cancer patients treated with paclitaxel. In addition to permanently limiting the patients’ quality of life, the development of CIPN often causes the treating physicians to reduce the administered dose of paclitaxel or even prematurely discontinue chemotherapy, which limits the success of treatment.
How can the neurological side effects of paclitaxel chemotherapy be reduced or, ideally, entirely prevented? This is the question being investigated by a research team at Charité led by Prof. Matthias Endres, who is head of the university hospital’s Department of Neurology and Experimental Neurology. The PREPARE study is investigating whether lithium may be effective at preventing paclitaxel-related neurological side effects.
In previous laboratory tests, the team was able to show that the administration of paclitaxel leads to an increase in calcium in neurons, which triggers programmed cell death in these cells. This calcium increase can be reduced by lithium ions, which protect the neurons from paclitaxel-induced damage. The scientists were able to confirm in an animal model that the preventive administration of lithium carbonate prevented CIPN from developing. The SPARK-BIH program began funding these extensive laboratory studies back in 2018.
In the PREPARE study, scientists are now testing for the first time whether the administration of lithium carbonate also prevents the development of neuropathies in breast cancer patients receiving chemotherapy with paclitaxel. Dr. Petra Hühnchen and Dr. Wolfgang Böhmerle, also from the Department of Neurology and Experimental Neurology, are coordinating the study, which is taking place at several hospitals (multicenter) with patients who are randomly assigned to a study arm (randomized), and neither the physician nor the patient knows whether the administered drug is lithium or a placebo (double-blind placebo-controlled). Lithium carbonate has been used successfully for many decades, especially in the treatment of depression and bipolar disorder.
Coming off the success of the laboratory studies, the scientists led by Prof. Matthias Endres were then able to plan the PREPARE study and launch it in April of this year. “Thanks to the extensive funding provided by the SPARK-BIH program, we were able to conduct basic preliminary studies and show in the animal model that the administration of lithium carbonate can prevent neurological side effects from occurring during chemotherapy without affecting the efficacy of paclitaxel,” explains Endres. “The results were so promising that we can now enter the first clinical phase of our research. We believe lithium carbonate has great potential to change the medical practice of using chemotherapy with paclitaxel in breast cancer – and possibly in other cancers too – in the long term.”
About the PREPARE study
The PREPARE study is currently recruiting a total of 84 study participants at Charité – Universitätsmedizin Berlin and seven other sites in Germany (Cottbus, Greifswald, Hamburg, Hanover, Giessen, Essen, Dresden, Leipzig), in close collaboration between Charité’s Department of Neurology and Experimental Neurology and certified local breast centers. The German Federal Ministry of Education and Research (BMBF) is supporting the study, which will run until late March 2025, to the tune of €696,000 under its funding program “Funding of Clinical Trials of High Relevance to Patient Care.”
About the SPARK-BIH program
SPARK-BIH is a mentoring program of Charité BIH Innovation. Originally established at Stanford University in 2006, SPARK is an initiative that supports clinicians and scientists through training, project management, mentoring, and milestone-based financial support. The aim is to foster outstanding applied medical research and to accelerate its translation into novel therapies, diagnostics, and medical devices.
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About the Berlin Institute of Health at Charité (BIH)
The mission of the Berlin Institute of Health at Charité (BIH) is medical translation: transferring biomedical research findings into novel approaches to personalized prediction, prevention, diagnostics and therapies and, conversely, using clinical observations to develop new research ideas. The aim is to deliver relevant medical benefits to patients and the population at large. As the translational research unit within Charité, the BIH is also committed to establishing a comprehensive translational ecosystem – one that places emphasis on a system-wide understanding of health and disease and that promotes change in the biomedical translational research culture. The BIH was founded in 2013 and is funded 90 percent by the Federal Ministry of Education and Research (BMBF) and 10 percent by the State of Berlin. The founding institutions, Charité – Universitätsmedizin Berlin and the Max Delbrück Center, were independent member entities within the BIH until 2020. Since 2021 the BIH has been integrated into Charité as its so-called third pillar. The Max Delbrück Center is now the Privileged Partner of the BIH.
https://www.bihealth.org/en/notices/can-the-neurological-side-effects-of-chemoth...
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