Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer

NCT01411943 | Completed

• 1 other identifier: HM13194
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

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. 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. 2.Inflammatory activation and epigenetic alterations are related to the temporal development, severity, and persistence of psychoneurologic symptoms.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years - 81 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from oncology treatment clinics

You may qualify if:

• At least 21 years of age
• Diagnosed with stage I to IIIa Breast Cancer
• Scheduled to receive chemotherapy

You may not qualify if:

• previous cancer history
• previous chemotherapy history
• dementia
• active psychosis

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (2)

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

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.

MeSH Terms

Conditions

Breast Neoplasms; Cognitive Dysfunction; Pain; Fatigue; Parasomnias; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Debra E Lyon, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 8, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

US (2)