Study of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
A Multicenter Evidence-Based Clinical Study on the Safety and Efficacy of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
This clinical trial aims to evaluate the efficacy of Wenyang Tongbi Granules (a patented Traditional Chinese Medicine prescription) in treating chemotherapy-induced peripheral neuropathy (CIPN). The study compares Wenyang Tongbi Granules with mecobalamin tablets, a standard clinical medication, to determine whether the TCM intervention yields superior outcomes in sensory and motor function of the limbs, as well as overall systemic status, among patients presenting with paresthesia and pain during chemotherapy.
Methods: Participants who develop hand-foot paresthesia or pain during chemotherapy will receive either Wenyang Tongbi Granules or mecobalamin tablets daily for a continuous period of 42 days. Evaluations will be conducted on Day 1, Day 21, and Day 42. Outcome measures include the severity and duration of limb paresthesia, as well as changes in TCM-specific syndromes. Additionally, blood samples will be collected to assess variations in serum levels of multiple cytokines, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), before and after the intervention.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名：YIN Yukun
- 电话号码：010-87788030
- 邮箱：qiuque20210303@163.com
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100021
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age: Patients aged between 18 and 80 years (inclusive).
- Life Expectancy: An anticipated survival time of ≥ 3 months.
- Performance Status & Organ Function: A Karnofsky Performance Status (KPS) score ≥ 60 and adequate organ function.
- Diagnosis: Histopathologically or cytologically confirmed breast cancer or colorectal cancer.
- Chemotherapy Regimen: Currently undergoing chemotherapy containing taxanes or oxaliplatin.
- Neurotoxicity Grade: Presence of Grade ≥ 2 peripheral neurotoxicity (according to NCI-CTCAE criteria) induced by chemotherapy.
- TCM Syndrome Differentiation: Conforming to the "Yang Deficiency and Collateral Obstruction with Toxin-Stasis Accumulation Pattern" as defined in the Guidelines for Clinical Research of New Traditional Chinese Medicines.
Exclusion Criteria:
- Allergy History: Known hypersensitivity to the active ingredients or excipients of the study drug/placebo; history of allergic constitution; or a history of allergies to ≥ 3 substances.
- Comorbidities: Presence of severe psychiatric disorders; or pre-existing conditions such as diabetic neuropathy, hypothyroidism, renal insufficiency, radiculopathy, Charcot-Marie-Tooth disease, or Guillain-Barré syndrome.
- Concomitant Medications: Use of Chinese patent medicines or herbal decoctions specifically for CIPN within 30 days prior to enrollment.
- Compliance: Inability to adhere to the treatment protocol or difficulty in accurately assessing one's own general condition.
- Pregnancy & Lactation: Pregnant or lactating women.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Decotion
Wenyang Tongbi Granules
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Placebo mecobalamin, one capsule per administration, three times daily (tid) with Wenyang Tongbi Granules (10 g/bag), administered as three bags per day for 42 consecutive days
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安慰剂比较：Placebo of decotion
Wenyang Tongbi Granules Placebo
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Mecobalamin (one capsule) administered three times daily (tid), combined with placebo Wenyang Tongbi Granules containing 5% of the original formula concentration (10 g/bag), administered as three bags per day for 42 consecutive days.
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有源比较器：comparator
Mecobalamin
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Mecobalamin (one capsule) administered three times daily (tid), combined with placebo Wenyang Tongbi Granules containing 5% of the original formula concentration (10 g/bag), administered as three bags per day for 42 consecutive days.
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安慰剂比较：Placebo of Mecobalamin
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Placebo mecobalamin, one capsule per administration, three times daily (tid) with Wenyang Tongbi Granules (10 g/bag), administered as three bags per day for 42 consecutive days
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Response Rate (ORR)
大体时间：At baseline (before treatment), Day 21, and Day 42.
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The evaluation was conducted with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). The outcomes were classified into four categories: Complete Response (CR), Partial Response (PR), No Change (NC), and Progressive Disease (PD). The Overall Response Rate (ORR) was calculated as follows: ORR= Total number of cases Number of CR + PR cases ×100% Definitions: Complete Response (CR): Reduction of adverse event grade to Grade 1. Partial Response (PR): A decrease of at least one grade compared to baseline (pre-treatment). No Change (NC): No improvement in symptoms or signs; or minimal symptomatic improvement without corresponding sign improvement. Progressive Disease (PD): An increase of at least one grade compared to baseline (pre-treatment). |
At baseline (before treatment), Day 21, and Day 42.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement rate of EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy（EORTC QLQ-CIPN20）scores.
大体时间：At baseline (before treatment), Day 21, and Day 42.
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The improvement rate was calculated using the formula: (Post-treatment score-Pre-treatment score×100%)/Pre-treatment score. This reflects the change in symptom burden and quality of life related to CIPN. The minimum value is 1 and maximum value is 4,the lower the better. |
At baseline (before treatment), Day 21, and Day 42.
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Remission rate of neuropathic pain assessed by Douleur Neuropathique 4 questions(DN4).
大体时间：At baseline (before treatment), Day 21, and Day 42.
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Pain remission was evaluated using the Douleur Neuropathique 4 questions (DN4)questionnaire. The remission rate was calculated as: (Pre-treatment score-Post-treatment score)/Pre-treatment score×100%.The minimum value is 1 and maximum value is 10,the lower the better. |
At baseline (before treatment), Day 21, and Day 42.
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Reduction rate of TCM syndrome scores.
大体时间：At baseline (before treatment), Day 21, and Day 42.
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According to the Guidelines for Clinical Research of New Traditional Chinese Medicines, the reduction rate was calculated based on the scoring criteria for "Yang Deficiency and Collateral Obstruction with Toxin-Stasis Accumulation Pattern".The minimum value is 1 and maximum value is 4,the lower the better.
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At baseline (before treatment), Day 21, and Day 42.
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Numbness distribution and symptom severity scores.
大体时间：At baseline (before treatment), Day 21, and Day 42.
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A novel supplementary rating scale was developed by our research group based on existing clinical scales and has been submitted for a national invention patent (Application No. 202511273259.8).The minimum value is 1 and maximum value is 10,the lower the better.
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At baseline (before treatment), Day 21, and Day 42.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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