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临床试验/NCT04669977
NCT04669977Unknown不适用

Treatment Effects of a Glucoside- and Rutinoside-rich Crude Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2020年12月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
246
试验地点
2
主要终点
Taiwanese version of the Brief Fatigue Inventory (BFI-T)

研究概览

简要总结

Chemotherapy-induced peripheral neuropathy (CIPN is common among cancer patients during or after chemotherapy, and the currently available drugs cannot effectively manage the symptoms. Besides, CIPN causes fatigue, anxiety, and depression. CIPN is featured by the interference of interleukin (IL) pathways, among which escalation of IL-17 is predominant, suggesting that IL-17 may be manipulated to reduce the inflammation or the immunological disturbance. Cyanidin, a type of glucosides, has been proved to behave like an IL-17 inhibitor. We have identified a food material that contains large amounts of glucosides and rutinosides - mulberry juice. The current proposal aims to explore the effect of this IL-17 inhibitor-rich material in CIPN and related symptoms. We plan to divide the potential participants into severe pain and mild pain group to conduct two human studies. A single-blinded randomized controlled design is adopted to compare the effects of this crude material between the experimental group and the control group in (1) pain and CIPN of the severe pain participants and (2) fatigue, anxiety, and depression in the mild pain participants. IL and other immune markers will be tested as evidence of improvement of inflammation status. We expect a decrement in pain, CIPN, fatigue, anxiety, and depression severity with the intake of this IL-17 inhibitor-rich material among cancer patients undergoing chemotherapy.

详细描述

Cancer is at least partially attributable to immunological disturbance, and its treatment causes additional inflammatory problems. Chemotherapy-induced peripheral neuropathy (CIPN), especially that induced by oxaliplatin or Taxanes (including paclitaxel and docetaxel) is common among cancer patients during or after the treatment of chemotherapeutic agents, presented as pain and sensory abnormalities for months, and even persists for years in some patients after the cessation of chemotherapy. Even worse is that currently available drugs cannot effectively manage these conditions. Besides, CIPN causes fatigue, anxiety, and depression, which lower patients' quality of life and determination to fight the disease. Interestingly, CIPN is featured by the interference of interleukin (IL) pathways, among which escalation of IL-17 is predominant, suggesting that IL-17 may be manipulated to reduce the inflammation or the immunological disturbance. Cyanidin, a type of glucosides, has been proved to behave like an IL-17 inhibitor and works in an animal model of skin hyperplasia in reducing the IL-17 levels and severity of hyperplasia. We have identified a food material that contains large amounts of glucosides and rutinosides - mulberry juice. Preliminary findings of an ongoing human study of our team have provided statistical evidence that this crude material effectively relieves clinical symptoms of a disorder associated with inflammation features. The current proposal aims to explore the effect of this IL-17 inhibitor-rich material in CIPN and related symptoms. To avoid confounding effects from pain, we plan to divide the potential participants into severe pain and mild pain group to conduct two human studies. A single-blinded randomized controlled design is adopted to compare the effects of this crude material between the experimental group and the control group in (1) pain and CIPN of the severe pain participants and (2) fatigue, anxiety, and depression in the mild pain participants. IL and other immune markers will be tested as evidence of improvement of inflammation status. We expect a decrement in pain, CIPN, fatigue, anxiety, and depression severity with the intake of this IL-17 inhibitor-rich material among cancer patients undergoing chemotherapy.

研究设计

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

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are eligible for study 1 (水 ffects of mulberry juice on pain and CIPN in participants with severe pain) if they have any cancer and are receiving the oxaliplatin or taxanes (paclitaxel and docetaxel) containing regimen weekly. Other inclusion criteria are (1) age ≥20 and <75 years; (2) performance status (PS) 0-2 according to the Eastern Cooperative Oncology Group (ECOG) scale; (3) life expectancy > 2 months. Visual analog scale (VAS) ≥
  • Subjects for study 2 (水 ffects of mulberry juice on fatigue, anxiety, and depression in participants with moderate pain) must meet all criteria above with the exception that the VAS should be <4.

排除标准

  • Patients are excluded if they (1) are not communicable; (2) have received radiotherapy within 4 weeks and cardiac dysfunction due to prior anthracyclines; (3) have symptomatic brain metastasis, symptomatic fluid retention, or severe comorbidities such as uncontrolled diabetes mellitus, severe hypertension or infection; (4) have psychiatric or social conditions that would prevent compliance with treatment, follow-up or adequate informed consent. Pregnant or lactating females are also ineligible.

结局指标

主要结局

Taiwanese version of the Brief Fatigue Inventory (BFI-T)

时间窗: Within 10 weeks

Assessment of the severity of CIPN

Visual analog scale (VAS)

时间窗: Within 10 weeks

Pain Assessment

Taiwanese version of Neuropathic pain symptom inventory (NPSI-T)

时间窗: Within 10 weeks

To evaluate the detail of pain of the patients, such as the quality of pain, numbness and tingling.

次要结局

  • Patient Health Questionnaire-9 items (PHQ-9)(Within 10 weeks)
  • Heart rate variability(Within 10 weeks)
  • General Anxiety Disorder-7 items (GAD-7)(Within 10 weeks)
  • Inflammation status(Within 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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