Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Epigenetics, Inflammatory, Psychoneurologic Symptoms, Cognitive Dysfunction, Pain, Fatigue, Sleep Disturbance, Depression, Depressive Symptoms, Anxiety, Breast Cancer
Study Type
Study Phase
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
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.
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:

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 81 Years
Minimum Age: 21 Years
Gender: Female
Criteria: 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
Peninsula Cancer Institute
Newport News, Virginia, United States
Status: Recruiting
Contact: Ora Mae Jackson, RN - 757-534-5565 - oramae.jackson@rivhs.com
Virginia Commonwealth University
Richmond, Virginia, United States
Status: Recruiting
Contact: Debra E Lyon, PhD - 804-828-5635 - delyon@vcu.edu
Start Date
January 2011
Completion Date
July 2015
Virginia Commonwealth University
Virginia Commonwealth University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page