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Completed

NCT Number: NCT01887925

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

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

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Key information

Conditions

Breast Neoplasms Anxiety Disorders Behavior Behavioral Symptoms Breast Diseases Depression Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 140-013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy

    Time frame: 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 outcomes

  1. Changes from Baseline Quality of Life at 1 Month After Chemotherapy

    Time frame: 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.

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

    Time frame: 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.

  3. Changes from Baseline Fatigue at 1 Month After Chemotherapy

    Time frame: 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.

  4. Changes from Baseline Depression at 1 Month After Chemotherapy

    Time frame: 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.

  5. Changes from Baseline Anxiety 1 Month After Chemotherapy

    Time frame: 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.

  6. Changes from Baseline PTSD Symptoms 1 Month After Chemotherapy

    Time frame: 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.

  7. Changes from Baseline Menopausal Symptoms 1 Month After Chemotherapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2013
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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