Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01411943

HM13194

Details and patient eligibility

About

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:

1. 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.
2. Inflammatory activation and epigenetic alterations are related to the temporal development, severity, and persistence of psychoneurologic symptoms.

Full 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:

1. 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
2. Levels of inflammation and to quantify the frequency and genome-wide location of changes in epigenetic patterns across time following chemotherapy
3. 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.

Enrollment: 75 patients

Sex: Female

Ages: 21 to 81 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 21 years of age
• Diagnosed with stage I to IIIa Breast Cancer
• Scheduled to receive chemotherapy

Exclusion criteria

• previous cancer history
• previous chemotherapy history
• dementia
• active psychosis