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临床试验/NCT07693374
NCT07693374撤回不适用

A Chinese Medicinal Component Relieves the Chemotherapy-induced Peripheral Neuropathy and the Relating Changes of Mitochondria Function in Dorsal Root Ganglion: Basic and Clinical Research

Taiwan Municipal An-Nan Hospital-China Medical University1 个研究点 分布在 1 个国家开始时间: 2022年8月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
BPI-SF;the Brief Pain Inventory-Short Form

研究概览

简要总结

A randomized controlled trial was designed and conducted to confirm whether oral administration of the herb Moutan Cortex, which contains paeonol, can alleviate peripheral neuropathy in paclitaxel-treated cancer patients. This research project will validate our new preliminary findings demonstrating the neuroprotective effects after paclitaxel treatment. Importantly, our data are expected to elucidate the way Moutan Cortex induces neuroprotection in the clinical setting and provide a scientific basis for the development of new approaches to treat CIPN.

详细描述

Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling pain condition that involves structural and functional impairment of peripheral motor, sensory, and autonomic neurons. CIPN symptoms may involve a combination of motor, sensory, and autonomic deficits. Sensory symptoms are the most common and are usually the first to appear, affecting the hands and feet the most. Sensory symptoms usually manifest as spontaneous or induced abnormal sensations, such as abnormal sensation, sensory dullness, numbness, burning, shooting or electric shock sensations, and unusual pain or pain hypersensitivity induced by mechanical or thermal stimuli. Paclitaxel drugs are among the most commonly used neurotoxic chemotherapeutic agents. In the absence of effective conventional treatments, there are limited effective ways to prevent or treat CIPN. The traditional Chinese medicine, Moutan Cortex, has long been used for its anticoagulant, anti-inflammatory, analgesic, and sedative activities, as well as for the treatment of cardiovascular, hemorrhagic, stagnated blood, and female genital disorders. Studies have shown that paeonol, a major component of Moutan Cortex, has analgesic, antipyretic and antibacterial properties, as well as anti-inflammatory, antioxidant and anti-platelet aggregation effects. It has a wide range of properties, such as inhibiting collagen-induced platelet aggregation and attenuating inflammatory responses in airways, coronary arteries, macrophages and microglia. Preliminary results in a baseline study showed that intraperitoneal administration of paclitaxel reduced the mechanical nociceptive threshold in the hind palm, indicating increased sensitivity to painful stimuli (mechanical allodynia pain). In contrast, the reduction in mechanical nociceptive threshold in the hind palm induced by paclitaxel was significantly reversed after oral administration of different doses of dandruff and approached that of the control group without paclitaxel, showing a significant improvement in mechanical anomalous pain. Therefore, a randomized controlled trial was designed and conducted to confirm whether oral administration of the herb Moutan Cortex, which contains paeonol, can alleviate peripheral neuropathy in paclitaxel-treated cancer patients. This research project will validate our new preliminary findings demonstrating the neuroprotective effects after paclitaxel treatment. Importantly, our data are expected to elucidate the way Moutan Cortex induces neuroprotection in the clinical setting and provide a scientific basis for the development of new approaches to treat CIPN.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult women above 20 years, diagnosed with stage I-III breast cancer by a histological analysis, and who had completed adjuvant or neoadjuvant neurotoxic chemotherapy (including taxane-based or platinum-based), with the severity of CIPN matching the definition of the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 version more than grade
  • In addition, the patients' daily physical status will match the definition of the Eastern Cooperative Oncology Group (ECOG) performance status less than grade 3

排除标准

  • metastatic breast cancer, a history of diabetic neurological disease before chemotherapy, other pre-existing peripheral neurological disorders, a history of inflammatory or metabolic arthritis, severe coagulopathy or potential bleeding tendency, dermatological disease within acupuncture needling area. Concomitant use of selected analgesics was allowed23 (e.g.,opioids, acetaminophen, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs]), but only patients receiving stable doses in the two weeks prior to randomization could participate: 1) no new analgesics were added; 2) no analgesics were discontinued; and 3) the weekly 24-hour total analgesic dose did not fluctuate up or down by > 10% in the two weeks prior to study registration

结局指标

主要结局

BPI-SF;the Brief Pain Inventory-Short Form

时间窗: BPI-SF will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)

The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form24 (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.

次要结局

  • SWM(SWM will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week))
  • The 13-item FACT/GOG-Ntx subscale(FACT/GOG-Ntx subscale will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week))

研究者

发起方
Taiwan Municipal An-Nan Hospital-China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chien-Chen Huang

M.D., PhD

Taiwan Municipal An-Nan Hospital-China Medical University

研究点 (1)

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