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Completed

NCT Number: NCT02011815

Exploring Biological Linkage Between Circadian Disruption and Cancer Progression

The purpose of this study is to explore the possible association between the circadian disruption and cancer progression.

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Key information

Conditions

Breast Neoplasms Anxiety Disorders Behavior Behavioral Symptoms Breast Diseases Depression Fatigue Mental Disorders Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms 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

The biological markers that are assumed to bridge this association are measured and analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18-70
  • Breast cancer patients who are getting chemotherapy for the first time in life
  • Patients are either having stage 4 cancer or starting neoadjuvant chemotherapy.
  • Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion criteria

  • Patients already have received chemotherapy
  • Patient had another cancer (except thyroid cancer) within 5 years
  • 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. Progression-free survival

    Time frame: 3 years (and more) after recruitment

    The data progression-free survival will be done by reviewing patients' medical record.

Secondary outcomes

  1. Circadian disruption

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment.

  2. Objective sleep cycle measures

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    The assessment will be performed by using actigraph and sleep diary.

  3. Physiological measures

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography.

  4. Sleep quality measures

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index.

  5. Quality of Life measure

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    The measurement will be performed using M.D. Anderson Symptom Inventory.

  6. Cancer related Fatigue

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    Fatigue severity scale will be used during the assessment.

  7. Distress related measure

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    Hospital Anxiety and Depression Scale will be used during the assessment.

  8. Posttraumatic Stress-related symptom measure

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients.

  9. Menopausal symptom measure

    Time frame: Baseline, after 1 month, after 6 month, after 12 month

    Menopause Rating Scale will be used during the assessment.

  10. Personality measure

    Time frame: Baseline

    Temperament and Character Inventory will be used to examine the personality factor in each participant.

  11. Genetic polymorphism

    Time frame: Baseline

    Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.

  12. Epigenetic Change

    Time frame: Baseline

    The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level.

  13. Cortisol level

    Time frame: Baseline

    Salivary cortisol level will be measured multiple times at baseline.

  14. Melatonin

    Time frame: Baseline

    Salivary or Urine melatonin level will be measured.

  15. Inflammatory markers

    Time frame: Baseline

    The various inflammation markers will be measured from blood sample.

  16. Overall survival

    Time frame: 3 years (and more) after recruitment

    The data progression-free survival will be done by reviewing patients' medical record.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Prospective Study of Exploring Possible Biological Linkage Between Circadian Disruption and Cancer Progression

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2013
Registry last updated
Sep 24, 2019

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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