NCT02011815
Completed
Not Applicable
A Prospective Study of Exploring Possible Biological Linkage Between Circadian Disruption and Cancer Progression
ConditionsBreast Neoplasms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Seoul National University Hospital
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 3 years (and more) after recruitment
The data progression-free survival will be done by reviewing patients' medical record.
Secondary Outcomes
- Objective sleep cycle measures(Baseline, after 1 month, after 6 month, after 12 month)
- Sleep quality measures(Baseline, after 1 month, after 6 month, after 12 month)
- Distress related measure(Baseline, after 1 month, after 6 month, after 12 month)
- Posttraumatic Stress-related symptom measure(Baseline, after 1 month, after 6 month, after 12 month)
- Genetic polymorphism(Baseline)
- Physiological measures(Baseline, after 1 month, after 6 month, after 12 month)
- Cortisol level(Baseline)
- Inflammatory markers(Baseline)
- Overall survival(3 years (and more) after recruitment)
- Quality of Life measure(Baseline, after 1 month, after 6 month, after 12 month)
- Cancer related Fatigue(Baseline, after 1 month, after 6 month, after 12 month)
- Menopausal symptom measure(Baseline, after 1 month, after 6 month, after 12 month)
- Epigenetic Change(Baseline)
- Circadian disruption(Baseline, after 1 month, after 6 month, after 12 month)
- Personality measure(Baseline)
- Melatonin(Baseline)
Study Sites (1)
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