Chemotherapy-induced Circadian Rhythm Disruption

NCT ID: NCT04364347

Last Updated: 2022-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-14

Study Completion Date

2023-02-28

Brief Summary

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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

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Conditions

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Breast Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bong-Jin Hahm, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang-Hyup Jung, M.D.

Role: CONTACT

82220723767

Facility Contacts

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Sang-Hyup Jung, M.D.

Role: primary

82220723767

References

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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.

Reference Type DERIVED
PMID: 40296750 (View on PubMed)

Related Links

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http://www.snuh.org/

study site webpage

https://cris.snuh.org/ncris/

Institutional Review Board

Other Identifiers

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CIRCADIAN

Identifier Type: -

Identifier Source: org_study_id

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