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

Study on the Intervention Effect of Roasted Nux Vomica on Bortezomib-Related Peripheral Neuropathy Based on lncRNA ZFAS1

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).

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma; Chemotherapy-Induced Peripheral Neuropathy
• Intervention / Treatment: Drug: Roasted Nux Vomica Capsules

Detailed Description

Study Background: Bortezomib is a first-line proteasome inhibitor for the treatment of multiple myeloma, but BIPN is one of its most common and dose-limiting adverse effects, which seriously affects the quality of life of patients and may lead to treatment discontinuation. Currently, there is no effective standard treatment for BIPN. Roasted Nux Vomica has been used in traditional Chinese medicine for centuries to treat pain and neurological disorders, and preliminary studies have shown its potential neuroprotective effects.

Study Design:This is a single-arm, open-label, prospective clinical study. A total of 22 eligible patients with multiple myeloma complicated with BIPN will be enrolled.

Intervention: All enrolled patients will receive oral Strychnos nux-vomica L. Capsules at a dose of 0.4 g three times daily for 6 consecutive weeks. All patients will continue to receive their original bortezomib-based chemotherapy regimen during the study period.

Outcome Measures

• Primary outcome: Change in NCI-CTCAE grade from baseline to weeks 2, 4, and 6.
• Secondary outcomes: Changes in TCM scores, FACT/GOG-NTx scale, and quality of life scores from baseline to weeks 2, 4, and 6.
• Exploratory outcome: Changes in the expression level of lncRNA ZFAS1 in peripheral blood mononuclear cells.

Ethical Considerations This study is conducted in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University. All patients will provide written informed consent before enrollment.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Confirmed diagnosis of multiple myeloma Developed peripheral neuropathy after receiving bortezomib-based chemotherapy Peripheral neuropathy meets the diagnostic criteria of bortezomib-induced peripheral neuropathy (BIPN) according to the 2015 Chinese Expert Consensus on the Diagnosis and Treatment of Multiple Myeloma Peripheral Neuropathy Aged between 18 and 85 years old Currently receiving bortezomib-based chemotherapy regimen Able to understand and sign the written informed consent form

Exclusion Criteria:

Prior use of nerve-damaging medications such as lenalidomide or thalidomide Severe cardiac, hepatic, or renal insufficiency (creatinine clearance ≤40 ml/min or serum creatinine ≥177 μmol/L) History of mental illness Known allergy or intolerance to Strychnos nux-vomica L. or any components of the study drug Pregnant or lactating women, or women planning to become pregnant Received other specific treatments for peripheral neuropathy within 4 weeks prior to enrollment Any medical condition that, in the investigator's judgment, may interfere with the study results or increase the risk to the participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Roasted Nux Vomica Capsules Intervention Group; All eligible patients with bortezomib-induced peripheral neuropathy (BIPN) received oral Roasted Nux Vomica Capsules at a dose of 0.4 g three times daily for 6 consecutive weeks. All patients continued to receive their original bortezomib-based chemotherapy regimen during the study period. Efficacy assessments were performed at baseline and at weeks 2, 4, and 6 after treatment initiation.

Drug: Roasted Nux Vomica Capsules; Roasted Nux Vomica Capsules is a hospital preparation approved by Zhejiang Provincial Medical Products Administration (Approval No.: Zhe Yao Zhi Zi Z20100263). Each capsule contains 0.2 g of processed Strychnos nux-vomica L. seed powder. Patients take 2 capsules (0.4 g) orally three times daily with warm water after meals for 6 consecutive weeks. All patients continue their original bortezomib-based chemotherapy regimen during the study period.; Other Names: oral Strychnos Nux-vomica L.capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NCI-CTCAE grade from Baseline to Week 6	Change in peripheral neuropathy grade as assessed by the NCI-CTCAE version 4.0. Grades range from 0 (no neuropathy) to 4 (life-threatening neuropathy).	Baseline, Week 2, Week 4, and Week 6 after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FACT/GOG-NTx Neurotoxicity Score from Baseline to Week 6	Change in patient-reported neurotoxicity as measured by the FACT/GOG-NTx scale. Higher scores indicate worse neurotoxicity.	Baseline, Week 2, Week 4, and Week 6 after treatment initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TCM syndrome score	Change in TCM syndrome score for peripheral neuropathy, which includes symptoms such as limb pain, numbness, coldness, and weakness. Higher scores indicate more severe symptoms.	Baseline, Week 2, Week 4, and Week 6 after treatment initiation

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Shu Deng, The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Neuroinflammation; Traditional Chinese Medicine; ZFAS1
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Inflammation; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Neuroinflammatory Diseases; Multiple Myeloma
• Other Study ID Numbers: 2021-K-263-01; 2021ZB092 (Other Grant/Funding Number: Zhejiang TCM Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of study participants. This study has a small sample size, and sharing individual-level data may increase the risk of participant re-identification. All aggregate study results will be published in peer-reviewed scientific journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No