Chemotherapy-induced Circadian Rhythm Disruption

• Conditions: Breast Neoplasms

• Registration Number: NCT04364347
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-14
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-10
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

1. Those who have undergone breast cancer surgery and are waiting for chemotherapy
2. premenopausal women
3. Invasive adenocarcinoma of the breast stages I-III

Exclusion Criteria

1. Other cancer diagnosis within the last 5 years
2. Other physical problems that can affect survival
3. 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.
4. ECOG(Eastern Cooperative Oncology Group performance status) >1
5. In the case of depression, anxiety disorder, sleep disorder, etc.
6. If you have worked night shifts or shifts within the past 6 months
7. Weight 40kg or less, digestive diseases, history of gastrointestinal surgery, etc.
8. If you are currently taking psychiatric drugs (antipsychotics, antidepressant, mood stabilizer, benzodiazepine, psychostimulant, beta-blocker, etc.)
9. If you have traveled on a transmeridian plane in the 3rd zone or more within the past 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in PBMC(Peripheral Blood Mononuclear Cell) mRNA levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy	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	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	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	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	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

Secondary Outcome Measures

Name	Time	Method
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)	MEQ(Morningness-Eveningness Questionnaire) / Individual circadian rhythm evaluation / Consists of 19 questions
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)	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
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)	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
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)	MDASI(M. D. Anderson Symptom Inventory) / Cancer-related physical symptoms evaluation / High score means severe physical symptoms
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)	PSQI(Pittsburgh Sleep Quality Index) / Evaluate sleep quality in the past month / High scores mean severe sleep disorders
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)	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
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)	MSPSS(Multidimensional Scale of Perceived Social Support) / Social support assessment / Self-report questionnaire of 12 items / High score means high social support
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)	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
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)	Assessment of the number and severity of hot flashes (mild, moderate, severe) for 1 week / High scores mean severe hot flush
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)	MCTQ(Munich Chronotype Questionnaire) / Assessment of circadian rhythm discrepancies
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)	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of