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Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer

This study is currently recruiting participants.
Verified May 2013 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01411943
First received: August 3, 2011
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years to 81 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from oncology treatment clinics

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411943

Contacts
Contact: Debra E Lyon, PhD 804-828-5635 delyon@vcu.edu

Locations
United States, Virginia
Peninsula Cancer Institute Recruiting
Newport News, Virginia, United States, 23601
Contact: Ora Mae Jackson, RN     757-534-5565 ext 1     oramae.jackson@rivhs.com    
Sub-Investigator: Guy Tillinghast, MD            
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Debra E Lyon, PhD     804-828-5635     delyon@vcu.edu    
Principal Investigator: Debra E Lyon, PhD            
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Debra E Lyon, PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01411943     History of Changes
Other Study ID Numbers: HM13194
Study First Received: August 3, 2011
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Epigenetics
Inflammatory
Psychoneurologic Symptoms
Cognitive Dysfunction
Pain
Fatigue
 Sleep Disturbance
Depression
Depressive Symptoms
Anxiety
Breast Cancer

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

ClinicalTrials.gov processed this record on June 18, 2013