Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411943
• Other study ID #: HM13194
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: December 7, 2015
• Start date: January 2011
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 81 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetics and psychoneurologic symptoms in women receiving chemotherapy for breast cancer	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.	5 years	No