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

Depression Clinical Trial

Official title:

Depression and IL-6 in Epithelial Ovarian Cancer: Genetic Diathesis and Psychological Stress

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00460200
• Other study ID #: CDR0000385692
• Secondary ID: UCLA-0309083-01U
• Status: Withdrawn
• Phase: N/A
• First received: April 11, 2007
• Last updated: October 3, 2012
• Start date: December 2003

Study information

• Verified date: October 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Fatigue
• Ovarian Cancer
• Ovarian Neoplasms
• Parasomnias
• Psychosocial Effects of Cancer and Its Treatment
• Sleep Disorders

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

• physiologic testing

• questionnaire administration

Procedure:
• conventional surgery

• fatigue assessment and management

• psychosocial assessment and care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Primary	Correlation of tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety			No
Primary	Effects of neuroendocrine activity on modulation of IL-6 production			No
Primary	Comparison of immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro			No
Primary	Correlation of levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment, and IL-6 parameters			No
Primary	Establishment of a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood			No
Primary	Incidence of herpes virus infections			No