Chemotherapy-induced Circadian Rhythm Disruption

NCT04364347 | Unknown

• 1 other identifier: CIRCADIAN
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Breast neoplasms; Circadian rhythm; Chemotherapy; Biomarker; Core body temperature; Melatonin; Cortisol; Circadian gene

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• 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 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 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 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)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

University (Tertiary) hospital, oncology clinic

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 140-013, South Korea

RECRUITING

Related Publications (1)

• Shin JS, Jung S, Won GH, Lee SH, Kim J, Jung S, Yeom CW, Lee KM, Son KL, Kim JI, Jeon SY, Lee HB, Hahm BJ. The Association Between Circadian Disruption in Core Body Temperature Rhythm and Post-Chemotherapy Sleep Disturbances in Breast Cancer Survivors. J Sleep Res. 2025 Apr 29:e70080. doi: 10.1111/jsr.70080. Online ahead of print.

  PMID: 40296750 DERIVED

Related Links

• study site webpage
• Institutional Review Board

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bong-Jin Hahm, M.D.,Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Hyup Jung, M.D.

CONTACT

82220723767; jshyup@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 28, 2020
• Study Start: December 14, 2019
• Primary Completion: October 1, 2022
• Study Completion: February 1, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

KR (1)