Breast NeoplasmsNCT01887925
The Effects of Circadian Gene on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy
An observational study of Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: university hospital, oncology clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 140-013
About this study
Official title: The Effects of Per3, Clock Polymorphism on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy.
The purpose of this study is the evaluation of effect of circadian gene on sleep and other symptoms in breast cancer patients under chemotherapy.
Read the detailed description
In this study, the investigators are going to examine the effect of genetic polymorphism on sleep, anxiety, depression and other cancer-related symptoms in patients with breast cancer who have started chemotherapy after surgery. No intervention was intended and blood sample was taken with other routine laboratory tests.
- Conditions
- Breast Neoplasms
- Keywords
- breast neoplasms, sleep, anxiety, depression, life quality
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer | breast cancer patients receiving chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Secondary outcomes (7)
Changes from Baseline Quality of Life at 1 Month After Chemotherapy
Quality of life will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month after completion of the chemotherapy.
Measured: baseline, 1 month after chemotherpy completion
Changes from Baseline Cancer-related Symptoms at 1 Month After Chemotherapy
Cancer-related symptoms 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.
Measured: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline Fatigue at 1 Month After Chemotherapy
Fatigue 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.
Measured: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline Depression at 1 Month After Chemotherapy
Depression 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.
Measured: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline Anxiety 1 Month After Chemotherapy
Anxiety 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.
Measured: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline PTSD Symptoms 1 Month After Chemotherapy
PTSD symptoms 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.
Measured: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline Menopausal Symptoms 1 Month After Chemotherapy
Menopausal symptoms 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.
Measured: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startFeb 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bong-Jin Hahm, Seoul National University Hospital
- Investigators
- Bong-Jin Hahm, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887925
- Sponsor's protocol ID
- BreastCaCTx_circadian
- Status last verified
- Nov 2015
- First submitted
- 20 Jun 2013
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35132840
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Per3, Clock Polymorphism on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy.
- ClinicalTrials.gov ID
- NCT01887925
- Acronym / sponsor ID
- BreastCaCTx_circadian
- Conditions
- Breast Neoplasms
- Keywords
- breast neoplasms, sleep, anxiety, depression, life quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is the evaluation of effect of circadian gene on sleep and other symptoms in breast cancer patients under chemotherapy.
Detailed description
In this study, the investigators are going to examine the effect of genetic polymorphism on sleep, anxiety, depression and other cancer-related symptoms in patients with breast cancer who have started chemotherapy after surgery. No intervention was intended and blood sample was taken with other routine laboratory tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer | – | –breast cancer patients receiving chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- university hospital, oncology clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy
Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
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.
7 secondary outcomes
Changes from Baseline Quality of Life at 1 Month After Chemotherapy
Time frame: baseline, 1 month after chemotherpy completion
Changes from Baseline Cancer-related Symptoms at 1 Month After Chemotherapy
Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline Fatigue at 1 Month After Chemotherapy
Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline Depression at 1 Month After Chemotherapy
Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline Anxiety 1 Month After Chemotherapy
Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline PTSD Symptoms 1 Month After Chemotherapy
Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Changes from Baseline Menopausal Symptoms 1 Month After Chemotherapy
Time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Derived from this study: PubMed 35132840Son 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.
- study siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bong-Jin Hahm, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy (time frame: baseline, 1 month, 3 months, 1 month after chemotherpy completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01887925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.