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).
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310006
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in NCI-CTCAE grade from Baseline to Week 6
Lasso di tempo: Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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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).
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Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in FACT/GOG-NTx Neurotoxicity Score from Baseline to Week 6
Lasso di tempo: Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Change in patient-reported neurotoxicity as measured by the FACT/GOG-NTx scale.
Higher scores indicate worse neurotoxicity.
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Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in TCM syndrome score
Lasso di tempo: Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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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.
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Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Shu Deng, The First Affiliated Hospital of Zhejiang Chinese Medical University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Processi patologici
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Infiammazione
- Malattie ematologiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Neoplasie, plasmacellule
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Disturbi emorragici
- Condizioni patologiche, segni e sintomi
- Malattie emiche e linfatiche
- Malattie neuroinfiammatorie
- Mieloma multiplo
Altri numeri di identificazione dello studio
- 2021-K-263-01
- 2021ZB092 (Altro numero di sovvenzione/finanziamento: Zhejiang TCM Administration)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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