Breast CancerNCT01411943
Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer
An observational study of Breast Cancer, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
This study examines the relationship among epigenetic alterations and the development and persistence of psychoneurologic symptoms (cognitive dysfunction, depressive symptoms, anxiety, fatigue, sleep disturbance, and pain) in women receiving chemotherapy for early stage breast cancer. Read more about this study
- Who is it for?
- Ages 21 to 81 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Jul 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 21 to 81 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from oncology treatment clinics
Who may be able to join
- At least 21 years of age
- Diagnosed with stage I to IIIa Breast Cancer
- Scheduled to receive chemotherapy
Who cannot join
- previous cancer history
- previous chemotherapy history
- dementia
- active psychosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Peninsula Cancer Institute
Newport News, Virginia, 23601
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders
This study examines the relationship among epigenetic alterations and the development and persistence of psychoneurologic symptoms (cognitive dysfunction, depressive symptoms, anxiety, fatigue, sleep disturbance, and pain) in women receiving chemotherapy for early stage breast cancer. The relationship among inflammatory markers and psychoneurologic symptoms will also be explored. It is hypothesized:
- Chemotherapy triggers inflammatory activation, which in turn leads to the acquisition of genetic alterations. These alterations result in cellular changes and are modified over time.
- Inflammatory activation and epigenetic alterations are related to the temporal development, severity, and persistence of psychoneurologic symptoms.
Read the detailed description
Advancements in breast cancer have resulted in increased survival rates; however, many women with breast cancer experience distressing symptoms. Inflammatory activation and epigenetic alterations have been associated with the etiology of cancer. To date, no investigators have considered these epigenetic processes as possible mechanisms associated with the etiology of distressing symptoms in women with breast cancer. The specific aims of this study are to examine:
- The frequency and severity of psychoneurological (PN) symptoms (depressive symptoms, anxiety, sleep disturbances, fatigue, pain and cognitive dysfunction)and the interrelationship among PN symptoms at each time point
- Levels of inflammation and to quantify the frequency and genome-wide location of changes in epigenetic patterns across time following chemotherapy
- The relationship among inflammation, epigenetic changes, and the development, severity, and persistence of PN symptoms across time The study results may potentially deepen understanding regarding the biological processes underlying PN symptoms and lead to improved strategies for symptom management in women with breast cancer.
- Conditions
- Breast Cancer
- Keywords
- Epigenetics, Inflammatory, Psychoneurologic Symptoms, Cognitive Dysfunction, Pain, Fatigue, Sleep Disturbance, Depression, Depressive Symptoms, Anxiety, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction, Pain, Fatigue, Parasomnias, Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer
To examine the frequency and severity of psychoneurologic symptoms and the interrelatednessamong the symptoms, levels of inflammation, and the frequency and genome wide localization of changes in epigenetic patterns across time.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra E Lyon, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411943
- Sponsor's protocol ID
- HM13194
- Status last verified
- Dec 2015
- First submitted
- 3 Aug 2011
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders
- ClinicalTrials.gov ID
- NCT01411943
- Acronym / sponsor ID
- HM13194
- Conditions
- Breast Cancer
- Keywords
- Epigenetics, Inflammatory, Psychoneurologic Symptoms, Cognitive Dysfunction, Pain, Fatigue, Sleep Disturbance, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Aug 2011 (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.
This study examines the relationship among epigenetic alterations and the development and persistence of psychoneurologic symptoms (cognitive dysfunction, depressive symptoms, anxiety, fatigue, sleep disturbance, and pain) in women receiving chemotherapy for early stage breast cancer. The relationship among inflammatory markers and psychoneurologic symptoms will also be explored. It is hypothesized:
- Chemotherapy triggers inflammatory activation, which in turn leads to the acquisition of genetic alterations. These alterations result in cellular changes and are modified over time.
- Inflammatory activation and epigenetic alterations are related to the temporal development, severity, and persistence of psychoneurologic symptoms.
Detailed description
Advancements in breast cancer have resulted in increased survival rates; however, many women with breast cancer experience distressing symptoms. Inflammatory activation and epigenetic alterations have been associated with the etiology of cancer. To date, no investigators have considered these epigenetic processes as possible mechanisms associated with the etiology of distressing symptoms in women with breast cancer. The specific aims of this study are to examine:
- The frequency and severity of psychoneurological (PN) symptoms (depressive symptoms, anxiety, sleep disturbances, fatigue, pain and cognitive dysfunction)and the interrelationship among PN symptoms at each time point
- Levels of inflammation and to quantify the frequency and genome-wide location of changes in epigenetic patterns across time following chemotherapy
- The relationship among inflammation, epigenetic changes, and the development, severity, and persistence of PN symptoms across time The study results may potentially deepen understanding regarding the biological processes underlying PN symptoms and lead to improved strategies for symptom management in women with breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 81 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from oncology treatment clinics
Key inclusion criteria (3 listed)
- At least 21 years of age
- Diagnosed with stage I to IIIa Breast Cancer
- Scheduled to receive chemotherapy
Key exclusion criteria (4 listed)
- previous cancer history
- previous chemotherapy history
- dementia
- active psychosis
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
Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer
Time frame: 5 years
To examine the frequency and severity of psychoneurologic symptoms and the interrelatednessamong the symptoms, levels of inflammation, and the frequency and genome wide localization of changes in epigenetic patterns across time.
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 8 Dec 2015.
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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.
Debra E Lyon, PhD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Virginia Commonwealth University at 2 sites in United States.
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 3 inclusion and 4 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 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2015.