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Clinical Trials/NCT01411943
NCT01411943
Completed
Not Applicable

Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders

Virginia Commonwealth University2 sites in 1 country75 target enrollmentJanuary 2011
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Virginia Commonwealth University
Enrollment
75
Locations
2
Primary Endpoint
Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
July 2015
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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
  • active psychosis

Outcomes

Primary Outcomes

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.

Study Sites (2)

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