Safety and efficacy of adjunct lithium carbonate for the prevention of paclitaxel-induced neurotoxicity in breast cancer: a multicentre randomised placebo-controlled phase 2 trial
Description
The data were generated in a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial investigating the safety and efficacy of adjunct lithium carbonate for the prevention of chemotherapy-induced neurotoxicity in patients with breast cancer receiving (nab-)paclitaxel. Participants were treated in eight outpatient oncology centres in Germany between August 2022 and July 2024. Patients were randomly assigned to receive oral lithium carbonate or matching placebo in addition to standard (nab-)paclitaxel chemotherapy. Study medication was initiated 10–14 days before the first chemotherapy cycle and continued until three days after the final administration. Lithium dosing was adjusted to achieve predefined target trough serum concentrations. Clinical, laboratory, neuropsychological, imaging, and patient-reported outcome data were collected prospectively at predefined study visits from baseline to post-treatment follow-up. The primary endpoint was chemotherapy-induced peripheral neuropathy assessed using the Total Neuropathy Score–reduced (TNSr). Secondary outcomes included serum neurofilament light chain concentrations as a biomarker of neuroaxonal injury, structural magnetic resonance imaging measures of total intracranial and hippocampal volume, cognitive performance assessed with the CANTAB test battery, patient-reported neuropathy symptoms, quality of life, anxiety and depression scores, analgesic use, cumulative chemotherapy dose, tumour response in the neoadjuvant setting, and adverse events. The shared dataset represents the de-identified data used for the statistical analyses of the trial.
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The data were generated in a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial investigating the safety and efficacy of adjunct lithium carbonate for the prevention of chemotherapy-induced neurotoxicity in patients with breast cancer receiving (nab-)paclitaxel. Participants were treated in eight outpatient oncology centres in Germany between August 2022 and July 2024. Patients were randomly assigned to receive oral lithium carbonate or matching placebo in addition to standard (nab-)paclitaxel chemotherapy. Study medication was initiated 10–14 days before the first chemotherapy cycle and continued until three days after the final administration. Lithium dosing was adjusted to achieve predefined target trough serum concentrations. Clinical, laboratory, neuropsychological, imaging, and patient-reported outcome data were collected prospectively at predefined study visits from baseline to post-treatment follow-up. The primary endpoint was chemotherapy-induced peripheral neuropathy assessed using the Total Neuropathy Score–reduced (TNSr). Secondary outcomes included serum neurofilament light chain concentrations as a biomarker of neuroaxonal injury, structural magnetic resonance imaging measures of total intracranial and hippocampal volume, cognitive performance assessed with the CANTAB test battery, patient-reported neuropathy symptoms, quality of life, anxiety and depression scores, analgesic use, cumulative chemotherapy dose, tumour response in the neoadjuvant setting, and adverse events. The shared dataset represents the de-identified data used for the statistical analyses of the trial. Files and variables File: 2023-06-05_PREPARE_Prüfplan_V1.4_final.pdf Description: Complete trial protocol File: SAP_PREPARE_final_signed.pdf Description: Statistical analysis plan File: PREPARE_De_Identified_Dataset.xml Description: Deidentified dataset currently in institutional review.
Institutions
- Charité - Universitätsmedizin BerlinBerlin, Berlin
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Funders
- Bundesministerium für Forschung, Technologie und RaumfahrtNorth Rhine-Westphalia, BonnGrant ID: 01KG2123