Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01411943
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease
Breast Cancer

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.

Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders
Study Start Date : January 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
This study will be examining cytokine and c-reactive protein levels, DNA methylation, DNA repair proteins, telomere length and chromosomal instability.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from oncology treatment clinics

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01411943

United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Principal Investigator: Debra E Lyon, PhD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University Identifier: NCT01411943     History of Changes
Other Study ID Numbers: HM13194
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Virginia Commonwealth University:
Psychoneurologic Symptoms
Cognitive Dysfunction
Sleep Disturbance
Depressive Symptoms
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases