Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer

Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01411943

Enrollment

Registered

2011-08-08

Start date

2011-01-31

Completion date

2015-07-31

Last updated

2015-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Epigenetics, Inflammatory, Psychoneurologic Symptoms, Cognitive Dysfunction, Pain, Fatigue, Sleep Disturbance, Depression, Depressive Symptoms, Anxiety, Breast Cancer

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 81 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer	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.

Countries

United States

Outcome results