Chemotherapy-induced Circadian Rhythm Disruption

Breast Neoplasms Clinical Trial

Official title:

Chemotherapy-induced Circadian Rhythm Disruption: Investigation Using Biomarker

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364347
• Other study ID #: CIRCADIAN
• Status: Recruiting
• Start date: December 14, 2019
• Est. completion date: February 2023

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Sang-Hyup Jung, M.D.
• Phone: 82220723767
• Email: jshyup[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: February 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	DNA	First one only	T0(2 weeks before the start of chemotherapy)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Institutional Review Board
•   study site webpage