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Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders

21 Years
81 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Debra E Lyon, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University


United States: Institutional Review Board

Study ID:




Start Date:

January 2011

Completion Date:

July 2015

Related Keywords:

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



Virginia Commonwealth University Richmond, Virginia  
Peninsula Cancer Institute Newport News, Virginia  23601