The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 255
- Locations
- 1
- Primary Endpoint
- Cohort 2 - Recurrence-free survival
Overview
Brief Summary
Cytomegalovirus (CMV), a widely prevalent virus in the general US population, has been shown to be associated with increased inflammation and mortality. Previous small pilot studies have demonstrated that latent CMV may be reactivated during chemotherapy in cancer patients, and may be associated with unfavorable cancer outcomes such as fatigue and increased mortality.
The central research idea for this study, supported by previous preliminary data, is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer that impacts patient outcomes. The overarching goals of this observational study are:
- To assess how CMV infection is associated with ovarian cancer symptoms over the course of the disease and its treatment.
- To describe the relationship between CMV reactivation in ovarian cancer patients, survival, fatigue, and other QOL outcomes, both cross-sectionally and longitudinally.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to read and write in English
- •women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer
- •Treatment plan includes chemotherapy
- •Able to provide written voluntary consent before performance of any study related procedure.
- •Cohort 1 only: within 2 years of completing initial chemotherapy treatment
- •Cohort 2 only: prior to starting chemotherapy
Exclusion Criteria
- •Inability to provide informed written consent
- •Previous exposure to chemotherapy
- •Life expectancy \< 3 months or in hospice care or nursing home
Outcomes
Primary Outcomes
Cohort 2 - Recurrence-free survival
Time Frame: 3 years
Time from diagnosis to first known recurrence or death, censored at least follow-up if recurrence free and alive
Cohort 1 - Cancer-related fatigue
Time Frame: post treatment
Cancer-related fatigue will be measured using the Fatigue Symptom Inventory. The scale is composed of 14 items (one is not scored). A total Disruption Index is calculated by summing items 5-11 (each item ranges from 0-10). A lower score indicates lower fatigue. Possible range is 0-70.
Secondary Outcomes
No secondary outcomes reported