Chemotherapy-induced Circadian Rhythm Disruption: Investigation Using Biomarker

Seoul National University Hospital1 site in 1 country27 target enrollmentDecember 14, 2019

ConditionsBreast Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Neoplasms
Sponsor: Seoul National University Hospital
Enrollment: 27
Locations: 1
Primary Endpoint: Changes in PBMC(Peripheral Blood Mononuclear Cell) mRNA levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 14, 2019

End Date

February 2023

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

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)

6 times in 24 hours at 4 hour intervals

Secondary Outcomes

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))