Chemotherapy-induced Circadian Rhythm Disruption: Investigation Using Biomarker
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Changes in PBMC(Peripheral Blood Mononuclear Cell) mRNA levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy
研究概览
简要总结
The purpose of this study is to investigate chemotherapy-induced circadian rhythm disruption through biomarkers, and the relationship between chemotherapy-induced circadian rhythm disruptions and side effects of chemotherapy.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Those who have undergone breast cancer surgery and are waiting for chemotherapy
- •premenopausal women
- •Invasive adenocarcinoma of the breast stages I-III
排除标准
- •Other cancer diagnosis within the last 5 years
- •Other physical problems that can affect survival
- •Other physical problems that can affect sleep or mood ex) pulmonary disease(COPD, Asthma), GI disorder(GERD), Renal disorder(End stage renal disease), Endocrine disorder(Hypothyroidism, Acromegaly), Infectious disease(Viral, bacterial infections, HIV infections), Neurological disease(epilepsy, parkinson's disease, neuromuscular disorder, stroke, multiple sclerosis), Cardiovascular disease(Coronary heart disease), Pain, etc.
- •ECOG(Eastern Cooperative Oncology Group performance status) >1
- •In the case of depression, anxiety disorder, sleep disorder, etc.
- •If you have worked night shifts or shifts within the past 6 months
- •Weight 40kg or less, digestive diseases, history of gastrointestinal surgery, etc.
- •If you are currently taking psychiatric drugs (antipsychotics, antidepressant, mood stabilizer, benzodiazepine, psychostimulant, beta-blocker, etc.)
- •If you have traveled on a transmeridian plane in the 3rd zone or more within the past 6 months.
结局指标
主要结局
Changes in PBMC(Peripheral Blood Mononuclear Cell) mRNA levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy
时间窗: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
12 times in 24 hours at 2 hour intervals
Changes in plasma melatonin, cortisol levels before, after and 9 months after chemotherapy
时间窗: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
12 times in 24 hours at 2 hour intervals
DNA
时间窗: T0(2 weeks before the start of chemotherapy)
First one only
Changes in core body temperature before chemotherapy, after chemotherapy, and 9 months after chemotherapy
时间窗: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
for 24 hours
Changes in plasma protein levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy
时间窗: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination)
6 times in 24 hours at 4 hour intervals
次要结局
- Changes in MEQ scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in MAT scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in EORTC-QLQ CIPN20 scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in MDASI scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in PSQI scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in HADS scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in MSPSS scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in FACT-B scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in Hot flush symptoms before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in MCTQ scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))
- Changes in Actigraphy pattern before chemotherapy, after chemotherapy, and 9 months after chemotherapy(T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), C3(Just before the third chemotherapy), C7(Just before the 7th chemotherapy), T2(9 months after chemotherapy termination))