The Effects of Per3, Clock Polymorphism on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy
Study Overview
Brief Summary
The purpose of this study is the evaluation of effect of circadian gene on sleep and other symptoms in breast cancer patients under chemotherapy.
Detailed Description
In this study, the investigators are going to examine the effect of genetic polymorphism on sleep, anxiety, depression and other cancer-related symptoms in patients with breast cancer who have started chemotherapy after surgery. No intervention was intended and blood sample was taken with other routine laboratory tests.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 18-70
- •Patient with breast cancer without metastasis
- •Patient received cancer surgery and medically stable
- •Patient will undergo chemotherapy for the first time in life
- •Patient have signed on the informed consent, and well understood the objective and procedure of this study
Exclusion Criteria
- •Patient received chemotherapy or radiotherapy
- •Patient had another cancer before
- •Patient have metastasis
- •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
Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy
Time Frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Sleep impairment will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy.
Secondary Outcomes
- Changes from Baseline Depression at 1 Month After Chemotherapy(baseline, 1 month, 3 months, 1 month after chemotherpy completion)
- Changes from Baseline Quality of Life at 1 Month After Chemotherapy(baseline, 1 month after chemotherpy completion)
- Changes from Baseline Cancer-related Symptoms at 1 Month After Chemotherapy(baseline, 1 month, 3 months, 1 month after chemotherpy completion)
- Changes from Baseline Fatigue at 1 Month After Chemotherapy(baseline, 1 month, 3 months, 1 month after chemotherpy completion)
- Changes from Baseline Anxiety 1 Month After Chemotherapy(baseline, 1 month, 3 months, 1 month after chemotherpy completion)
- Changes from Baseline PTSD Symptoms 1 Month After Chemotherapy(baseline, 1 month, 3 months, 1 month after chemotherpy completion)
- Changes from Baseline Menopausal Symptoms 1 Month After Chemotherapy(baseline, 1 month, 3 months, 1 month after chemotherpy completion)
Investigators
Bong-Jin Hahm
professor
Seoul National University Hospital