Exploring Biological Linkage Between Circadian Disruption and Cancer Progression
- Conditions
- Breast Neoplasms
- Registration Number
- NCT02011815
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The purpose of this study is to explore the possible association between the circadian disruption and cancer progression.
- Detailed Description
The biological markers that are assumed to bridge this association are measured and analyzed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 236
- Age: 18-70
- Breast cancer patients who are getting chemotherapy for the first time in life
- Patients are either having stage 4 cancer or starting neoadjuvant chemotherapy.
- Patient have signed on the informed consent, and well understood the objective and procedure of this study
- Patients already have received chemotherapy
- Patient had another cancer (except thyroid cancer) within 5 years
- Patient with severe medical condition
- Patient had taken psychiatric medication more than 1 month in life
- Patient worked the night shift for more than 1 month in 6 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival 3 years (and more) after recruitment The data progression-free survival will be done by reviewing patients' medical record.
- Secondary Outcome Measures
Name Time Method Objective sleep cycle measures Baseline, after 1 month, after 6 month, after 12 month The assessment will be performed by using actigraph and sleep diary.
Sleep quality measures Baseline, after 1 month, after 6 month, after 12 month The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index.
Distress related measure Baseline, after 1 month, after 6 month, after 12 month Hospital Anxiety and Depression Scale will be used during the assessment.
Posttraumatic Stress-related symptom measure Baseline, after 1 month, after 6 month, after 12 month Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients.
Genetic polymorphism Baseline Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.
Physiological measures Baseline, after 1 month, after 6 month, after 12 month The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography.
Cortisol level Baseline Salivary cortisol level will be measured multiple times at baseline.
Inflammatory markers Baseline The various inflammation markers will be measured from blood sample.
Overall survival 3 years (and more) after recruitment The data progression-free survival will be done by reviewing patients' medical record.
Quality of Life measure Baseline, after 1 month, after 6 month, after 12 month The measurement will be performed using M.D. Anderson Symptom Inventory.
Cancer related Fatigue Baseline, after 1 month, after 6 month, after 12 month Fatigue severity scale will be used during the assessment.
Menopausal symptom measure Baseline, after 1 month, after 6 month, after 12 month Menopause Rating Scale will be used during the assessment.
Epigenetic Change Baseline The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level.
Circadian disruption Baseline, after 1 month, after 6 month, after 12 month Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment.
Personality measure Baseline Temperament and Character Inventory will be used to examine the personality factor in each participant.
Melatonin Baseline Salivary or Urine melatonin level will be measured.
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Jongno-gu, Korea, Republic of