Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer

October 3, 2012 updated by: Jonsson Comprehensive Cancer Center

Depression and IL-6 in Epithelial Ovarian Cancer: Genetic Diathesis and Psychological Stress

RATIONALE: Measuring levels of interleukin-6 and depression may help doctors understand the relationship between interleukin-6 and depression. It may also help the study of cancer in the future.

PURPOSE: This clinical trial is studying depression and interleukin-6 production in patients with ovarian epithelial cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Correlate tumor production of interleukin (IL)-6, serum levels of IL-6, and IL-6 coding or promoter single nucleotide polymorphisms with IL-6 protein production in patients with ovarian epithelial cancer.
  • Correlate tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety in these patients to determine whether catecholamines or cortisol may alter production of IL-6 by cultured ovarian cancer cells.
  • Determine the effects of neuroendocrine activity on modulation of IL-6 production in these patients.
  • Compare immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro.
  • Correlate the levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment (e.g., in a pre- vs post-therapy sampling framework), and IL-6 parameters in these patients.
  • Determine the use of epitope prediction bioinformatic tools in consultation with Coulter to set up a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood from these patients.
  • Determine the incidence of herpes virus infections in these patients.

OUTLINE: This is a pilot study.

Before and after cytoreduction surgery, patients complete multiple questionnaires, including Beck Depression Inventory, Positive & Negative Mood State, Fatigue Symptom Inventory, Revised NEO Personality Inventory, COPE, SF-36, Pittsburgh Sleep Quality Inventory, and Mental Adjustment to Cancer, to assess depression and coping mechanisms.

Blood samples are collected at baseline and on postoperative days 1-4 and analyzed for interleukin (IL)-6, c-reactive protein, herpes simplex virus-8 (HSV8), epinephrine, adrenocorticotropic hormones, and cortisol. Ovarian carcinoma tissue samples and peritoneal fluid are also collected and evaluated for production and utilization of IL-6, HSV8, and autonomic nervous system and hypothalamic-pituitary-adrenal activity.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

diagnosis of ovarian epithelial cancer

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of ovarian epithelial cancer
  • Scheduled to undergo cytoreduction of ovarian tumor

PATIENT CHARACTERISTICS:

  • Able to communicate with the investigator

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Correlation of tumor production of interleukin (IL)-6, serum levels of IL-6, and IL-6 coding or promoter single nucleotide polymorphisms with IL-6 protein production
Correlation of tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety
Effects of neuroendocrine activity on modulation of IL-6 production
Comparison of immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro
Correlation of levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment, and IL-6 parameters
Establishment of a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood
Incidence of herpes virus infections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Leah Z. Fitzgerald, RN, PhD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 11, 2007

First Posted (Estimate)

April 13, 2007

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000385692
  • UCLA-0309083-01
  • UCLA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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