Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer
|ClinicalTrials.gov Identifier: NCT01411943|
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : December 8, 2015
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.
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||75 participants|
|Official Title:||Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders|
|Study Start Date :||January 2011|
|Primary Completion Date :||March 2015|
|Study Completion Date :||July 2015|
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411943
|United States, Virginia|
|Peninsula Cancer Institute|
|Newport News, Virginia, United States, 23601|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Debra E Lyon, PhD||Virginia Commonwealth University|