Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer
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|ClinicalTrials.gov Identifier: NCT00460200|
Recruitment Status : Withdrawn (no patient accrual)
First Posted : April 13, 2007
Last Update Posted : October 4, 2012
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.
|Condition or disease||Intervention/treatment|
|Depression Fatigue Ovarian Cancer Psychosocial Effects of Cancer and Its Treatment Sleep Disorders||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|
- 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|
|Actual Enrollment :||0 participants|
|Official Title:||Depression and IL-6 in Epithelial Ovarian Cancer: Genetic Diathesis and Psychological Stress|
|Study Start Date :||December 2003|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460200
|Principal Investigator:||Leah Z. Fitzgerald, RN, PhD||Jonsson Comprehensive Cancer Center|