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

NCT ID: NCT01887925

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms

Keywords

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breast neoplasms sleep anxiety depression life quality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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breast cancer

breast cancer patients receiving chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bong-Jin Hahm

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bong-Jin Hahm, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 35132840 (View on PubMed)

Related Links

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http://www.snuh.org/

study site

Other Identifiers

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BreastCaCTx_circadian

Identifier Type: -

Identifier Source: org_study_id