Exploring Biological Linkage Between Circadian Disruption and Cancer Progression

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

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

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

Conditions
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Breast Neoplasms

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer<br>Diagnosed breast cancer patients who are getting chemotherapy for the first time. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The data progression-free survival will be done by reviewing patients' medical record. | 3 years (and more) after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian disruption | Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment. | Baseline, after 1 month, after 6 month, after 12 month | 
| Objective sleep cycle measures | The assessment will be performed by using actigraph and sleep diary. | Baseline, after 1 month, after 6 month, after 12 month | 
| Physiological measures | The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography. | Baseline, after 1 month, after 6 month, after 12 month | 
| Sleep quality measures | The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index. | Baseline, after 1 month, after 6 month, after 12 month | 
| Quality of Life measure | The measurement will be performed using M.D. Anderson Symptom Inventory. | Baseline, after 1 month, after 6 month, after 12 month | 
| Cancer related Fatigue | Fatigue severity scale will be used during the assessment. | Baseline, after 1 month, after 6 month, after 12 month | 
| Distress related measure | Hospital Anxiety and Depression Scale will be used during the assessment. | Baseline, after 1 month, after 6 month, after 12 month | 
| Posttraumatic Stress-related symptom measure | Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients. | Baseline, after 1 month, after 6 month, after 12 month | 
| Menopausal symptom measure | Menopause Rating Scale will be used during the assessment. | Baseline, after 1 month, after 6 month, after 12 month | 
| Personality measure | Temperament and Character Inventory will be used to examine the personality factor in each participant. | Baseline | 
| Genetic polymorphism | Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined. | Baseline | 
| Epigenetic Change | The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level. | Baseline | 
| Cortisol level | Salivary cortisol level will be measured multiple times at baseline. | Baseline | 
| Melatonin | Salivary or Urine melatonin level will be measured. | Baseline | 
| Inflammatory markers | The various inflammation markers will be measured from blood sample. | Baseline | 
| Overall survival | The data progression-free survival will be done by reviewing patients' medical record. | 3 years (and more) after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distress, Breast neoplasms, Circadian rhythm, sleep, survival, anxiety, depression, quality of life, actigraph, fatigue