Clinical trial NCT04364347: Chemotherapy-induced Circadian Rhythm Disruption
Official title: Chemotherapy-induced Circadian Rhythm Disruption: Investigation Using Biomarker
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: Breast neoplasms
Circadian rhythm
Chemotherapy
Biomarker
Core body temperature
Melatonin
Cortisol
Circadian gene
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2020-04-28
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University (Tertiary) hospital, oncology clinic

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in plasma melatonin, cortisol levels before, after and 9 months after chemotherapy
timeFrame: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
measure: Changes in core body temperature before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
measure: Changes in PBMC(Peripheral Blood Mononuclear Cell) mRNA levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)
measure: Changes in plasma protein levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: DNA
timeFrame: T0(2 weeks before the start of chemotherapy)
Secondary outcomes:
measure: Changes in MAT scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in EORTC-QLQ CIPN20 scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in Hot flush symptoms before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in MEQ scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in MCTQ scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in FACT-B scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in MDASI scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in HADS scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in MSPSS scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in PSQI scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
measure: Changes in Actigraphy pattern before chemotherapy, after chemotherapy, and 9 months after chemotherapy
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Bong-Jin Hahm, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: