Chemotherapy-Induced Peripheral Neuropathy, Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Neuroinflammation, Traditional Chinese Medicine, ZFAS1
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).
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.
Interventions
DRUGRoasted 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.
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NCI-CTCAE grade from Baseline to Week 6 | Baseline, Week 2, Week 4, and Week 6 after treatment initiation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FACT/GOG-NTx Neurotoxicity Score from Baseline to Week 6 | Baseline, Week 2, Week 4, and Week 6 after treatment initiation | Change in patient-reported neurotoxicity as measured by the FACT/GOG-NTx scale. Higher scores indicate worse neurotoxicity. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORShu Deng
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed