The Effects of Circadian Gene on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy

Seoul National University Hospital224 enrolled

Overview

The purpose of this study is the evaluation of effect of circadian gene on sleep and other symptoms in breast cancer patients under chemotherapy.

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 Type

OBSERVATIONAL

Enrollment

224

Conditions

Breast Neoplasms

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Outcomes

Primary Outcomes

Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy

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.

Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion

Secondary Outcomes

Changes from Baseline Quality of Life at 1 Month After Chemotherapy

Quality of life will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month after completion of the chemotherapy.

Time frame: baseline, 1 month after chemotherpy completion

Changes from Baseline Cancer-related Symptoms at 1 Month After Chemotherapy

Cancer-related symptoms 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.

Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion

Changes from Baseline Fatigue at 1 Month After Chemotherapy

Fatigue 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.

Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion

Changes from Baseline Depression at 1 Month After Chemotherapy

Depression 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.

Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion

Data from ClinicalTrials.gov

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