Trials / Withdrawn
WithdrawnNCT00460200
Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer
Depression and IL-6 in Epithelial Ovarian Cancer: Genetic Diathesis and Psychological Stress
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2003-12-01
- First posted
- 2007-04-13
- Last updated
- 2012-10-04
Source: ClinicalTrials.gov record NCT00460200. Inclusion in this directory is not an endorsement.