Exploring Biological Linkage Between Circadian Disruption and Cancer Progression

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011815
• Other study ID #: BreastCA_circa_mech
• Status: Completed
• Start date: November 10, 2013
• Est. completion date: June 15, 2019

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	The data progression-free survival will be done by reviewing patients' medical record.	3 years (and more) after recruitment
Secondary	Circadian disruption	Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment.	Baseline, after 1 month, after 6 month, after 12 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cancer related Fatigue	Fatigue severity scale will be used during the assessment.	Baseline, after 1 month, after 6 month, after 12 month
Secondary	Distress related measure	Hospital Anxiety and Depression Scale will be used during the assessment.	Baseline, after 1 month, after 6 month, after 12 month
Secondary	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
Secondary	Menopausal symptom measure	Menopause Rating Scale will be used during the assessment.	Baseline, after 1 month, after 6 month, after 12 month
Secondary	Personality measure	Temperament and Character Inventory will be used to examine the personality factor in each participant.	Baseline
Secondary	Genetic polymorphism	Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.	Baseline
Secondary	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
Secondary	Cortisol level	Salivary cortisol level will be measured multiple times at baseline.	Baseline
Secondary	Melatonin	Salivary or Urine melatonin level will be measured.	Baseline
Secondary	Inflammatory markers	The various inflammation markers will be measured from blood sample.	Baseline
Secondary	Overall survival	The data progression-free survival will be done by reviewing patients' medical record.	3 years (and more) after recruitment

External Links

•   Institutional Review Board
•   study site webpage