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.
Study Type
OBSERVATIONAL
Enrollment
27
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
RECRUITINGChanges in plasma melatonin, cortisol levels before, after and 9 months after chemotherapy
12 times in 24 hours at 2 hour intervals
Time frame: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
Changes in core body temperature before chemotherapy, after chemotherapy, and 9 months after chemotherapy
for 24 hours
Time frame: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
Changes in PBMC(Peripheral Blood Mononuclear Cell) mRNA levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy
12 times in 24 hours at 2 hour intervals
Time frame: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
Changes in plasma protein levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy
6 times in 24 hours at 4 hour intervals
Time frame: 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)
DNA
First one only
Time frame: T0(2 weeks before the start of chemotherapy)
Changes in MAT scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
MAT(Multinational Association of Supportive Care in Cancer Antiemesis tool) / Evaluating acute/delayed nausea and vomiting in patients treated with chemotherapy / High scores mean severe nausea and vomiting
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Time frame: 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
EORTC-QLQ CIPN20(European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-induced Peripheral Neuropathy) / Peripheral neuropathy evaluation (It consists of 9 questions of sensory nerve area, 8 questions of motor nerve area and 3 questions of autonomic nerve area.) / High scores mean severe peripheral neuropathy
Time frame: 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
Assessment of the number and severity of hot flashes (mild, moderate, severe) for 1 week / High scores mean severe hot flush
Time frame: 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 MEQ scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
MEQ(Morningness-Eveningness Questionnaire) / Individual circadian rhythm evaluation / Consists of 19 questions
Time frame: 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
MCTQ(Munich Chronotype Questionnaire) / Assessment of circadian rhythm discrepancies
Time frame: 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
FACT-B(Functional Assessment of Cancer Therapy-Breast) / Measuring the quality of life of breast cancer patients / Self-report questionnaire of 44 items / High score means low quality of life
Time frame: 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
MDASI(M. D. Anderson Symptom Inventory) / Cancer-related physical symptoms evaluation / High score means severe physical symptoms
Time frame: 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
HADS(Hospital anxiety and depression scale) / Depression, anxiety evaluation of patients with physical illness / Self-report questionnaire with 14 items / High score means severe depression and anxiety symptoms
Time frame: 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
MSPSS(Multidimensional Scale of Perceived Social Support) / Social support assessment / Self-report questionnaire of 12 items / High score means high social support
Time frame: 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
PSQI(Pittsburgh Sleep Quality Index) / Evaluate sleep quality in the past month / High scores mean severe sleep disorders
Time frame: 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
Activity measurement / Records information such as weekly activity, time to go to bed, sleep incubation period, number of awakenings during sleep, wake-up time, and brightness of ambient light
Time frame: 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)