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Exploring Biological Linkage Between Circadian Disruption and Cancer Progression

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02011815
First received: December 10, 2013
Last updated: June 24, 2016
Last verified: June 2016

December 10, 2013
June 24, 2016
November 2013
December 2016   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 3 years (and more) after recruitment ] [ Designated as safety issue: No ]
The data progression-free survival will be done by reviewing patients' medical record.
  • Survival [ Time Frame: 3 years (and more) after recruitment ] [ Designated as safety issue: No ]
    The data on survival will be verified via Statistics Korea.
  • Progression-free survival [ Time Frame: 3 years (and more) after recruitment ] [ Designated as safety issue: No ]
    The data progression-free survival will be done by reviewing patients' medical record.
Complete list of historical versions of study NCT02011815 on ClinicalTrials.gov Archive Site
  • Circadian disruption [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment.
  • Objective sleep cycle measures [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    The assessment will be performed by using actigraph and sleep diary.
  • Physiological measures [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography.
  • Sleep quality measures [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index.
  • Quality of Life measure [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    The measurement will be performed using M.D. Anderson Symptom Inventory.
  • Cancer related Fatigue [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Fatigue severity scale will be used during the assessment.
  • Distress related measure [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale will be used during the assessment.
  • Posttraumatic Stress-related symptom measure [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients.
  • Menopausal symptom measure [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Menopause Rating Scale will be used during the assessment.
  • Personality measure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Temperament and Character Inventory will be used to examine the personality factor in each participant.
  • Genetic polymorphism [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.
  • Epigenetic Change [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level.
  • Cortisol level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Salivary cortisol level will be measured multiple times at baseline.
  • Melatonin [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Salivary or Urine melatonin level will be measured.
  • Inflammatory markers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The various inflammation markers will be measured from blood sample.
  • Overall survival [ Time Frame: 3 years (and more) after recruitment ] [ Designated as safety issue: No ]
    The data progression-free survival will be done by reviewing patients' medical record.
  • Circadian disruption [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment.
  • Objective sleep cycle measures [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    The assessment will be performed by using actigraph and sleep diary.
  • Physiological measures [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography.
  • Sleep quality measures [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index.
  • Quality of Life measure [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    The measurement will be performed using M.D. Anderson Symptom Inventory.
  • Cancer related Fatigue [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Fatigue severity scale will be used during the assessment.
  • Distress related measure [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale will be used during the assessment.
  • Posttraumatic Stress-related symptom measure [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients.
  • Menopausal symptom measure [ Time Frame: Baseline, after 1 month, after 6 month, after 12 month ] [ Designated as safety issue: No ]
    Menopause Rating Scale will be used during the assessment.
  • Personality measure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Temperament and Character Inventory will be used to examine the personality factor in each participant.
  • Genetic polymorphism [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.
  • Epigenetic Change [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level.
  • Cortisol level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Salivary cortisol level will be measured multiple times at baseline.
  • Melatonin [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Salivary or Urine melatonin level will be measured.
  • Inflammatory markers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The various inflammation markers will be measured from blood sample.
Not Provided
Not Provided
 
Exploring Biological Linkage Between Circadian Disruption and Cancer Progression
A Prospective Study of Exploring Possible 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.
The biological markers that are assumed to bridge this association are measured and analyzed.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood, serum Saliva Urine
Non-Probability Sample
University (Tertiary) hospital, oncology clinic
Breast Neoplasms
Not Provided
Breast cancer
Diagnosed breast cancer patients who are getting chemotherapy for the first time.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
236
March 2017
December 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years   (Adult, Senior)
No
Contact: Dooyoung Y Jung, M.D. 82220723767 dooyoung@gmail.com
Korea, Republic of
 
NCT02011815
BreastCA_circa_mech
Yes
Not Provided
Not Provided
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Bong-Jin Hahm, M.D., Ph.D. Seoul National University Hospital
Seoul National University Hospital
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP