Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer
NCT ID: NCT00460200
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2003-12-31
Brief Summary
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PURPOSE: This clinical trial is studying depression and interleukin-6 production in patients with ovarian epithelial cancer.
Detailed Description
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* 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
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Keywords
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Study Design
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PROSPECTIVE
Interventions
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polymorphism analysis
laboratory biomarker analysis
physiologic testing
questionnaire administration
conventional surgery
fatigue assessment and management
psychosocial assessment and care
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
55 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Leah Z. Fitzgerald, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Other Identifiers
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UCLA-0309083-01
Identifier Type: -
Identifier Source: secondary_id
UCLA-002
Identifier Type: -
Identifier Source: secondary_id
CDR0000385692
Identifier Type: -
Identifier Source: org_study_id