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

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT01887925
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-27
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy	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 Outcome Measures

Name	Time	Method
Changes from Baseline Depression at 1 Month After Chemotherapy	baseline, 1 month, 3 months, 1 month after chemotherpy completion	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.
Changes from Baseline Quality of Life at 1 Month After Chemotherapy	baseline, 1 month after chemotherpy completion	Quality of life will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month after completion of the chemotherapy.
Changes from Baseline Cancer-related Symptoms at 1 Month After Chemotherapy	baseline, 1 month, 3 months, 1 month after chemotherpy completion	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.
Changes from Baseline Fatigue at 1 Month After Chemotherapy	baseline, 1 month, 3 months, 1 month after chemotherpy completion	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.
Changes from Baseline Anxiety 1 Month After Chemotherapy	baseline, 1 month, 3 months, 1 month after chemotherpy completion	Anxiety 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.
Changes from Baseline PTSD Symptoms 1 Month After Chemotherapy	baseline, 1 month, 3 months, 1 month after chemotherpy completion	PTSD 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.
Changes from Baseline Menopausal Symptoms 1 Month After Chemotherapy	baseline, 1 month, 3 months, 1 month after chemotherpy completion	Menopausal 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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of