Exploring Biological Linkage Between Circadian Disruption and Cancer Progression

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02011815

Collaborator

(none)

236

Enrollment

Location

67.1

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

236 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 10, 2013

Actual Primary Completion Date :

Feb 15, 2019

Actual Study Completion Date :

Jun 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Breast cancer Diagnosed breast cancer patients who are getting chemotherapy for the first time.

Outcome Measures

Primary Outcome Measures

Progression-free survival [3 years (and more) after recruitment]
The data progression-free survival will be done by reviewing patients' medical record.

Secondary Outcome Measures

Circadian disruption [Baseline, after 1 month, after 6 month, after 12 month]
Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment.
Objective sleep cycle measures [Baseline, after 1 month, after 6 month, after 12 month]
The assessment will be performed by using actigraph and sleep diary.
Physiological measures [Baseline, after 1 month, after 6 month, after 12 month]
The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography.
Sleep quality measures [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.
Quality of Life measure [Baseline, after 1 month, after 6 month, after 12 month]
The measurement will be performed using M.D. Anderson Symptom Inventory.
Cancer related Fatigue [Baseline, after 1 month, after 6 month, after 12 month]
Fatigue severity scale will be used during the assessment.
Distress related measure [Baseline, after 1 month, after 6 month, after 12 month]
Hospital Anxiety and Depression Scale will be used during the assessment.
Posttraumatic Stress-related symptom measure [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.
Menopausal symptom measure [Baseline, after 1 month, after 6 month, after 12 month]
Menopause Rating Scale will be used during the assessment.
Personality measure [Baseline]
Temperament and Character Inventory will be used to examine the personality factor in each participant.
Genetic polymorphism [Baseline]
Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.
Epigenetic Change [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.
Cortisol level [Baseline]
Salivary cortisol level will be measured multiple times at baseline.
Melatonin [Baseline]
Salivary or Urine melatonin level will be measured.
Inflammatory markers [Baseline]
The various inflammation markers will be measured from blood sample.
Overall survival [3 years (and more) after recruitment]
The data progression-free survival will be done by reviewing patients' medical record.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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