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"The Effect of Memantine on the Prevention and Amelioration of Paclitaxel-induced Toxicity in Breast Cancer Patients"

RecruitingPhase 2Ages 18 Years - anyFemaleAin Shams University
NCT06679387 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Cancer is currently a leading cause of morbidity and mortality worldwide. Chemotherapeutic agents, despite being effective in arresting the progression of cancer by targeting and eliminating rapidly dividing cancer cells, are associated with various adverse effects. Chemotherapy-induced peripheral neuropathy (CIPN) is a serious clinical adverse effect of certain chemotherapeutic agents. For many patients, CIPN symptoms could be severe, disabling, and significantly impairing the activities of daily living (ADL) and diminishing the quality of life (QoL). Paclitaxel-induced peripheral neuropathy may affect up to 97% of paclitaxel-treated patients and become chronic in more than 60% of cases. The initial symptoms of paclitaxel-induced peripheral neuropathy (PIPN) include numbness, tingling, and allodynia (painful sensations in response to normally non-painful stimuli) that can be manifested

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients (\>18 years old). * Patients with confirmed diagnosis of non-metastatic breast cancer planned to receive weekly adjuvant/neo-adjuvant paclitaxel. * Patients with Eastern Cooperative Oncology Group (ECOG) performance (Oken et al., 1982) status of 0-2. Exclusion Criteria: * Patients with pre-existing neuropathic conditions. * Patients with diabetes mellitus. * Patients with a history of seizure disorder. * Patients with renal impairment (creatinine clearance less than 60 ml/min), or hepatic impairment (defined as ALT an AST \> 3 times upper limits of normal) * Patients with inadequate bone marrow functions (defined as absolute neutrophilic count less than 1,500/mm3 or platelets count less than 100,000/mm3). * Concomitant use of vitamin B1, B6, B9, or B12. * Patients receiving medications that possibly induce peripheral neuropathy including amiodarone, colchicine, metronidazole, antimycobacterials, and nucleoside reverse transcriptase inhibitors, and phenytoin (Jones et al., 2020). * Patients receiving gabapentinoids, antidepressants, or opioids. * Pregnancy or lactation. * History of hypersensitivity to memantine.
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What it tests

  • Memantine-HCl
  • Placebo Oral Tablet
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Where

1 site
Ain shams University Hospitals
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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