Clinical trial NCT02011815: Exploring Biological Linkage Between Circadian Disruption and Cancer Progression
Official title: A Prospective Study of Exploring Possible Biological Linkage Between Circadian Disruption and Cancer Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: Breast neoplasms
Circadian rhythm
sleep
survival
distress
anxiety
depression
quality of life
actigraph
fatigue
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University (Tertiary) hospital, oncology clinic

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

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

Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years (and more) after recruitment
Secondary outcomes:
measure: Circadian disruption
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Objective sleep cycle measures
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Physiological measures
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Sleep quality measures
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Quality of Life measure
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Cancer related Fatigue
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Distress related measure
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Posttraumatic Stress-related symptom measure
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Menopausal symptom measure
timeFrame: Baseline, after 1 month, after 6 month, after 12 month
measure: Personality measure
timeFrame: Baseline
measure: Genetic polymorphism
timeFrame: Baseline
measure: Epigenetic Change
timeFrame: Baseline
measure: Cortisol level
timeFrame: Baseline
measure: Melatonin
timeFrame: Baseline
measure: Inflammatory markers
timeFrame: Baseline
measure: Overall survival
timeFrame: 3 years (and more) after recruitment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Bong-Jin Hahm, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: