Exploring Biological Linkage Between Circadian Disruption and Cancer Progression

NCT02011815 | Completed DMC

• 1 other identifier: BreastCA_circa_mech
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms

Keywords

Breast neoplasms; Circadian rhythm; sleep; survival; distress; anxiety; depression; quality of life; actigraph; fatigue

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The data progression-free survival will be done by reviewing patients' medical record.

  3 years (and more) after recruitment

Secondary Outcomes (16)

• Circadian disruption

  Baseline, after 1 month, after 6 month, after 12 month

• Objective sleep cycle measures

  Baseline, after 1 month, after 6 month, after 12 month

• Physiological measures

  Baseline, after 1 month, after 6 month, after 12 month

• Sleep quality measures

  Baseline, after 1 month, after 6 month, after 12 month

• Quality of Life measure

  Baseline, after 1 month, after 6 month, after 12 month

Study Arms (1)

Breast cancer

Diagnosed breast cancer patients who are getting chemotherapy for the first time.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University (Tertiary) hospital, oncology clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 140-013, South Korea

Location

Related Links

• study site webpage
• Institutional Review Board

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum Saliva Urine

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bong-Jin Hahm, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: November 10, 2013
• Primary Completion: February 15, 2019
• Study Completion: June 15, 2019
• Last Updated: September 24, 2019

Record last verified: 2018-04

Locations

KR (1)