Clinical trial · Observational
Chemotherapy-induced Circadian Rhythm Disruption
Chemotherapy-induced Circadian Rhythm Disruption: Investigation Using Biomarker
NCT04364347CI-TRIAL-00058281unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- 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)
- description
- 12 times in 24 hours at 2 hour intervals
- 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)
- description
- for 24 hours
- 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)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDShin 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. PMID 40296750