Clinical trial NCT01887925: The Effects of Circadian Gene on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy
Official title: The Effects of Per3, Clock Polymorphism on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: breast neoplasms
sleep
anxiety
depression
life quality
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: university hospital, oncology clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy
timeFrame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Secondary outcomes:
measure: Changes from Baseline Quality of Life at 1 Month After Chemotherapy
timeFrame: baseline, 1 month after chemotherpy completion
measure: Changes from Baseline Cancer-related Symptoms at 1 Month After Chemotherapy
timeFrame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
measure: Changes from Baseline Fatigue at 1 Month After Chemotherapy
timeFrame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
measure: Changes from Baseline Depression at 1 Month After Chemotherapy
timeFrame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
measure: Changes from Baseline Anxiety 1 Month After Chemotherapy
timeFrame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
measure: Changes from Baseline PTSD Symptoms 1 Month After Chemotherapy
timeFrame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
measure: Changes from Baseline Menopausal Symptoms 1 Month After Chemotherapy
timeFrame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Bong-Jin Hahm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Son KL, Jung D, Lee KM, Yeom CW, Oh GH, Kim TY, Im SA, Lee KH, Spiegel D, Hahm BJ. Morning Chronotype Decreases the Risk of Chemotherapy-Induced Peripheral Neuropathy in Women With Breast Cancer. J Korean Med Sci. 2022 Feb 7;37(5):e34. doi: 10.3346/jkms.2022.37.e34.