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

Jonsson Comprehensive Cancer Center

Status: Withdrawn

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

Treatments: Other: physiologic testing; Procedure: fatigue assessment and management; Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: psychosocial assessment and care; Procedure: conventional surgery; Genetic: polymorphism analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00460200

CDR0000385692

UCLA-0309083-01

UCLA-002

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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