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

NCT07614243 | Completed

• 2 other identifiers: 2021-K-263-012021ZB092
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Multiple Myeloma; Chemotherapy-Induced Peripheral Neuropathy

Keywords

Multiple Myeloma; Neuroinflammation; Traditional Chinese Medicine; ZFAS1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in FACT/GOG-NTx Neurotoxicity Score from Baseline to Week 6

  Baseline, Week 2, Week 4, and Week 6 after treatment initiation

Other Outcomes (1)

• Change in TCM syndrome score

  Baseline, Week 2, Week 4, and Week 6 after treatment initiation

Study Arms (1)

Roasted Nux Vomica Capsules Intervention Group

EXPERIMENTAL

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

Interventions

Roasted Nux Vomica Capsules DRUG

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.

Also known as: oral Strychnos Nux-vomica L.capsules

Roasted Nux Vomica Capsules Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Multiple Myeloma; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shu Deng

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, open-label, prospective clinical study using a pre-post self-controlled design. All eligible patients received the same intervention of Roasted Nux Vomica Capsules.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: August 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)