Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Depression and IL-6 in Epithelial Ovarian Cancer: Genetic Diathesis and Psychological Stress |
- 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 [ Designated as safety issue: No ]
- Correlation of tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety [ Designated as safety issue: No ]
- Effects of neuroendocrine activity on modulation of IL-6 production [ Designated as safety issue: No ]
- Comparison of immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro [ Designated as safety issue: No ]
- Correlation of levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment, and IL-6 parameters [ Designated as safety issue: No ]
- Establishment of a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood [ Designated as safety issue: No ]
- Incidence of herpes virus infections [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | December 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
diagnosis of ovarian epithelial cancer
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00460200 History of Changes |
| Other Study ID Numbers: | CDR0000385692, UCLA-0309083-01, UCLA-002 |
| Study First Received: | April 11, 2007 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
depression fatigue sleep disorders psychosocial effects of cancer and its treatment ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Fatigue Ovarian Neoplasms Sleep Disorders Parasomnias Stress, Psychological Neoplasms, Glandular and Epithelial Behavioral Symptoms Mood Disorders Mental Disorders Signs and Symptoms Endocrine Gland Neoplasms |
Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Nervous System Diseases Neurologic Manifestations Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013