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).
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310006
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in NCI-CTCAE grade from Baseline to Week 6
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in FACT/GOG-NTx Neurotoxicity Score from Baseline to Week 6
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in TCM syndrome score
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Shu Deng, The First Affiliated Hospital of Zhejiang Chinese Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2021-K-263-01
- 2021ZB092 (기타 보조금/기금 번호: Zhejiang TCM Administration)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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