Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Anxiety Disorders Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Cognition Disorders Cognitive Dysfunction Depression Fatigue Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Wake Disorders

Age range

21 year–81 year

Sex eligibility

Female

Study type

Observational

Primary location

Peninsula Cancer Institute, Newport News, Virginia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Aug 8, 2011
Registry last updated: Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed