Clinical trial NCT01411943: Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer
Official title: Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Epigenetics
Inflammatory
Psychoneurologic Symptoms
Cognitive Dysfunction
Pain
Fatigue
Sleep Disturbance
Depression
Depressive Symptoms
Anxiety
Breast Cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from oncology treatment clinics

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.

Eligibility 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

Primary outcomes:
measure: Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Debra E Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
References: