EGCG for the Prevention and Treatment of TIPN
Trial Parameters
Brief Summary
Patients treated with paclitaxel analogs and experiencing Taxane-induced peripheral neurotoxicity (TIPN) of degree I or higher were treated with EGCG solution. The safety of topical EGCG solution for the treatment of TIPN and the optimal drug concentration were also verified by a phase I trial. The efficacy and safety of the optimal EGCG concentration obtained in the phase I trial were further analyzed in a randomized controlled phase II trial. Meanwhile, the predictive molecules of TIPN efficacy were initially explored by detecting patients' hematological related indexes. The optimal dose concentration, safety and efficacy of EGCG to ameliorate the neurotoxicity caused by paclitaxel-related drugs were clarified.
Eligibility Criteria
Inclusion Criteria: * Patients with histologically confirmed cancer * Received ≥1 cycle of systemic chemotherapy with albumin-bound paclitaxel * Adequate hematologic, hepatic, and kidney function profile * CIPN was evaluated by CTCAE as grade ≥2 * Urine or serum pregnancy test within 3 days prior to first dose in female subjects of childbearing potential * Subjects were willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and compliance with other requirements of the study. Exclusion Criteria: * The presence of a pre-existing condition that may result in a high risk of neuropathy: diabetes mellitus, thyroid disease, prior treatment with other medications that may result in neurological damage, alcoholism, familial neuropathy * Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study * Have taken medication for the treatment or prevention of