Exploring Biological Linkage Between Circadian Disruption and Cancer Progression

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 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: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Exploring Possible Biological Linkage Between Circadian Disruption and Cancer Progression

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Whole blood, serum Saliva Urine


Estimated Enrollment: 236
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer
Diagnosed breast cancer patients who are getting chemotherapy for the first time.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

University (Tertiary) hospital, oncology clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011815

Contacts
Contact: Dooyoung Y Jung, M.D. 82220723767 dooyoung@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Jongno-gu, Korea, Republic of, 140-013
Contact: Dooyoung Y Jung, M.D.    82220723767    dooyoung@gmail.com   
Principal Investigator: Bong-Jin Hahm, M.D., Ph.D.         
Sub-Investigator: Dooyoung Y Jung, M.D.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Bong-Jin Hahm, M.D., Ph.D. Seoul National University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02011815     History of Changes
Other Study ID Numbers: BreastCA_circa_mech
Study First Received: December 10, 2013
Last Updated: December 12, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Breast neoplasms
Circadian rhythm
sleep
survival
distress
anxiety
depression
quality of life
actigraph
fatigue

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 29, 2014