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


N/A
18 Years
55 Years
Not Enrolling
Female
Depression, Fatigue, Ovarian Cancer, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Leah Z. Fitzgerald, RN, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000385692

NCT ID:

NCT00460200

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Depression
  • Fatigue
  • Ovarian Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sleep Disorders
  • depression
  • fatigue
  • sleep disorders
  • psychosocial effects of cancer and its treatment
  • ovarian epithelial cancer
  • Depression
  • Depressive Disorder
  • Fatigue
  • Ovarian Neoplasms
  • Sleep Disorders
  • Parasomnias
  • Stress, Psychological
  • Neoplasms, Glandular and Epithelial

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