Chemotherapy-induced Circadian Rhythm Disruption

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Chemotherapy-induced Circadian Rhythm Disruption: Investigation Using Biomarker

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who have undergone breast cancer surgery and are waiting for chemotherapy premenopausal women Invasive adenocarcinoma of the breast stages I-III Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma melatonin, cortisol levels before, after and 9 months after chemotherapy | 12 times in 24 hours at 2 hour intervals | 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 | 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 | 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 | 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 | T0(2 weeks before the start of chemotherapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast neoplasms, Circadian rhythm, Chemotherapy, Biomarker, Core body temperature, Melatonin, Cortisol, Circadian gene