Clinical Trial

Long Non-coding RNA (lncRNA) ZFAS1-Mediated Mechanism of Roasted Nux Vomica in Intervening Bortezomib-Induced Peripheral Neuropathy

Study acronym: ZFAS1-BIPN
Completed
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Summary
This study aims to evaluate the efficacy and safety of Roasted Nux Vomica Capsules in the treatment of BIPN in patients with multiple myeloma. A total of 22 patients with multiple myeloma who developed peripheral neuropathy after receiving bortezomib-based chemotherapy will be enrolled at the First Affiliated Hospital of Zhejiang Chinese Medical University. All patients will receive oral Roasted Nux Vomica Capsules at a dose of 0.4 g three times daily for 6 consecutive weeks. The researchers will assess the severity of peripheral neuropathy assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, traditional Chinese medicine symptom (TCM) scores, and neurotoxicity scores measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTx) scale at baseline (before treatment) and at 2, 4, and 6 weeks after starting treatment. The study will also explore the underlying mechanism of Roasted Nux Vomica in treating BIPN through the lncRNA ZFAS1 pathway. This study has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (Approval Number: 2021-K-263-01).
Trial Details
NCT Number NCT07614243
Lead Sponsor The First Affiliated Hospital of Zhejiang Chinese Medical University
Conditions Multiple Myeloma, Chemotherapy-Induced Peripheral Neuropathy
Enrollment 22 participants
Start Date 2020-08-01
Primary Completion 2022-08-31 (estimated)
Study Completion 2022-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-29