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

This study has been withdrawn prior to enrollment.
(no patient accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00460200
First received: April 11, 2007
Last updated: October 3, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

diagnosis of ovarian epithelial cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460200

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Leah Z. Fitzgerald, RN, PhD Jonsson Comprehensive Cancer Center
  More 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:
Fatigue
Depression
Depressive Disorder
Sleep Disorders
Parasomnias
Ovarian Neoplasms
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 16, 2014