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


N/A
18 Years
70 Years
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

The Effects of Per3, Clock Polymorphism on Sleep and Associated 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy

Outcome Description:

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.

Outcome Time Frame:

baseline, 1 month, 3 months, 1 month after chemotherpy completion

Safety Issue:

No

Principal Investigator

Bong-Jin Hahm, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Institutional Review Board

Study ID:

BreastCaCTx_circadian

NCT ID:

NCT01887925

Start Date:

February 2012

Completion Date:

February 2014

Related Keywords:

  • Breast Neoplasms
  • breast neoplasms
  • sleep
  • anxiety
  • depression
  • life quality
  • Breast Neoplasms
  • Neoplasms

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