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

Breast Neoplasms Clinical Trial

Official title:

The Effects of Per3, Clock Polymorphism on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887925
• Other study ID #: BreastCaCTx_circadian
• Status: Completed
• Phase: N/A
• First received: June 20, 2013
• Last updated: November 27, 2015
• Start date: February 2012
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 1 month, 3 months, 1 month after chemotherpy completion	No
Secondary	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.	baseline, 1 month after chemotherpy completion	No
Secondary	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.	baseline, 1 month, 3 months, 1 month after chemotherpy completion	No
Secondary	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.	baseline, 1 month, 3 months, 1 month after chemotherpy completion	No
Secondary	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.	baseline, 1 month, 3 months, 1 month after chemotherpy completion	No
Secondary	Changes from Baseline Anxiety 1 Month After Chemotherapy	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.	baseline, 1 month, 3 months, 1 month after chemotherpy completion	No
Secondary	Changes from Baseline PTSD Symptoms 1 Month After Chemotherapy	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.	baseline, 1 month, 3 months, 1 month after chemotherpy completion	No
Secondary	Changes from Baseline Menopausal Symptoms 1 Month After Chemotherapy	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.	baseline, 1 month, 3 months, 1 month after chemotherpy completion	No

External Links

•   study site