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Breast NeoplasmsNCT04364347

Chemotherapy-induced Circadian Rhythm Disruption

An observational study of Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Breast Neoplasms
How many people
27 participants
Where
1 siteSouth Korea
Study dates
14 Dec 2019to Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: University (Tertiary) hospital, oncology clinic

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sang-Hyup Jung, M.D. contact

82220723767

jshyup@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, Jongno-gu, 140-013

    Sang-Hyup Jung, M.D., 82220723767, jshyup@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: Chemotherapy-induced Circadian Rhythm Disruption: Investigation Using Biomarker

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.

Keywords
Breast neoplasms, Circadian rhythm, Chemotherapy, Biomarker, Core body temperature, Melatonin, Cortisol, Circadian gene
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in plasma melatonin, cortisol levels before, after and 9 months after chemotherapy

    12 times in 24 hours at 2 hour intervals

    Measured: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)

  2. Changes in core body temperature before chemotherapy, after chemotherapy, and 9 months after chemotherapy

    for 24 hours

    Measured: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)

  3. 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

    Measured: T0(2 weeks before the start of chemotherapy), T1(2 weeks after chemotherapy termination), T2(9 months after chemotherapy termination)

  4. Changes in plasma protein levels before chemotherapy, after chemotherapy, and 9 months after chemotherapy

    6 times in 24 hours at 4 hour intervals

    Measured: 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)

  5. DNA

    First one only

    Measured: T0(2 weeks before the start of chemotherapy)

Secondary outcomes (11)

  1. 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

    Measured: 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)

  2. 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

    Measured: 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)

  3. 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

    Measured: 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)

  4. 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

    Measured: 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)

  5. Changes in MCTQ scores before chemotherapy, after chemotherapy, and 9 months after chemotherapy

    MCTQ(Munich Chronotype Questionnaire) / Assessment of circadian rhythm discrepancies

    Measured: 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. 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

    Measured: 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)

  7. 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

    Measured: 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)

  8. 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

    Measured: 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)

  9. 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

    Measured: 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)

  10. 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

    Measured: 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)

  11. 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start14 Dec 2019
  3. Primary completionOct 2022 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04364347
Sponsor's protocol ID
CIRCADIAN
Status last verified
May 2022
First submitted
21 Apr 2020
Last updated
5 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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. 2026 Apr;35(2):e70080. doi: 10.1111/jsr.70080. Epub 2025 Apr 29.

    PubMed 40296750

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sang-Hyup Jung, M.D. (82220723767, jshyup@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04364347, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.

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Chemotherapy-induced Circadian Rhythm Disruption | AzTrials