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临床试验/NCT03252834
NCT03252834终止不适用

To Study the Individual Variants of Chemotherapy-induced Abnormal Thermal Sensation in Cancer Patients

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
The change of thermal pain threshold

研究概览

简要总结

This is a prospective, single arm, single center study evaluating the use of a 4-gene panel to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial and ovarian cancer patients receiving post-operative chemotherapy with Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July~ 2019 June. Blood sample will be collected before chemotherapy to analyze the genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D & CIPN20). The primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in cancer patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 20 years old
  • Pathological stage I~IV for ovarian cancer, stage II~IV for endometrial cancer, or stage III for colorectal cancer.
  • Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer.
  • Patient willing to provide blood sample for research purposes.
  • Ability of the patient to provide informed consent.

排除标准

  • Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids.
  • Receiving chemotherapy within 6 months.
  • A family history of a genetic or familial neuropathy
  • Poor compliance

结局指标

主要结局

The change of thermal pain threshold

时间窗: before chemotherapy & 3, 6, and 9 months after chemotherapy

The threshold of detecting heat-induced pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meng-Ru Shen

Associate Dean for Research

National Cheng-Kung University Hospital

研究点 (1)

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