The Effects of Circadian Gene on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy

NCT01887925 | Completed DMC

• 1 other identifier: BreastCaCTx_circadian
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is the evaluation of effect of circadian gene on sleep and other symptoms in breast cancer patients under chemotherapy.

Conditions

Breast Neoplasms

Keywords

breast neoplasms; sleep; anxiety; depression; life quality

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy

  Sleep impairment will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy.

  baseline, 1 month, 3 months, 1 month after chemotherpy completion

Secondary Outcomes (7)

• Changes from Baseline Quality of Life at 1 Month After Chemotherapy

  baseline, 1 month after chemotherpy completion

• Changes from Baseline Cancer-related Symptoms at 1 Month After Chemotherapy

  baseline, 1 month, 3 months, 1 month after chemotherpy completion

• Changes from Baseline Fatigue at 1 Month After Chemotherapy

  baseline, 1 month, 3 months, 1 month after chemotherpy completion

• Changes from Baseline Depression at 1 Month After Chemotherapy

  baseline, 1 month, 3 months, 1 month after chemotherpy completion

• Changes from Baseline Anxiety 1 Month After Chemotherapy

  baseline, 1 month, 3 months, 1 month after chemotherpy completion

Study Arms (1)

breast cancer

breast cancer patients receiving chemotherapy

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 hospital, oncology clinic

You may qualify if:

• Age: 18-70
• Patient with breast cancer without metastasis
• Patient received cancer surgery and medically stable
• Patient will undergo chemotherapy for the first time in life
• Patient have signed on the informed consent, and well understood the objective and procedure of this study

You may not qualify if:

• Patient received chemotherapy or radiotherapy
• Patient had another cancer before
• Patient have metastasis
• 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 Publications (1)

• Son KL, Jung D, Lee KM, Yeom CW, Oh GH, Kim TY, Im SA, Lee KH, Spiegel D, Hahm BJ. Morning Chronotype Decreases the Risk of Chemotherapy-Induced Peripheral Neuropathy in Women With Breast Cancer. J Korean Med Sci. 2022 Feb 7;37(5):e34. doi: 10.3346/jkms.2022.37.e34.

  PMID: 35132840 DERIVED

Related Links

• study site

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Bong-Jin Hahm, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 27, 2013
• Study Start: February 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

KR (1)