To Study the Individual Variants of Chemotherapy-induced Abnormal Thermal Sensation in Cancer Patients
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
- 否
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
Meng-Ru Shen
Associate Dean for Research
National Cheng-Kung University Hospital
