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

25 maj 2026 uppdaterad av: The First Affiliated Hospital of Zhejiang Chinese Medical University

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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

22

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • oral Strychnos Nux-vomica L.capsules

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in NCI-CTCAE grade from Baseline to Week 6
Tidsram: 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).
Baseline, Week 2, Week 4, and Week 6 after treatment initiation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in FACT/GOG-NTx Neurotoxicity Score from Baseline to Week 6
Tidsram: 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.
Baseline, Week 2, Week 4, and Week 6 after treatment initiation

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in TCM syndrome score
Tidsram: Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Utredare

  • Huvudutredare: Shu Deng, The First Affiliated Hospital of Zhejiang Chinese Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2020

Primärt slutförande (Faktisk)

31 augusti 2022

Avslutad studie (Faktisk)

31 augusti 2022

Studieregistreringsdatum

Först inskickad

18 maj 2026

Först inskickad som uppfyllde QC-kriterierna

25 maj 2026

Första postat (Faktisk)

29 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2021-K-263-01
  • 2021ZB092 (Annat bidrag/finansieringsnummer: Zhejiang TCM Administration)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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