Depression Clinical Trial
Official title:
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.
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.
;
Time Perspective: Prospective
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