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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Fatigue, Ovarian Cancer, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders

Intervention / Treatment
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* Genetic: polymorphism analysis
* Other: laboratory biomarker analysis
* Other: physiologic testing
* Other: questionnaire administration
* Procedure: conventional surgery
* Procedure: fatigue assessment and management
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: polymorphism analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Other: physiologic testing|nan|
|Other: questionnaire administration|nan|
|Procedure: conventional surgery|nan|
|Procedure: fatigue assessment and management|nan|
|Procedure: psychosocial assessment and care|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, fatigue, sleep disorders, psychosocial effects of cancer and its treatment, ovarian epithelial cancer