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Depression, Cytokines and Pancreatic Cancer


N/A
40 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Depression, Cytokines and Pancreatic Cancer


Pancreatic cancer is the 5th leading cause of cancer mortality in the United States, with a
5 year mortality rate of over 95%. With limited treatments available for cure or
prolongation of survival, quality of life issues, such as the optimal treatment and
understanding of depression, become an important focus of care in this population. Clinical
Depression (Major Depressive Syndrome) occurs in up to 50% of patients with pancreatic
cancer, and is significantly more common than in other cancers. Accumulating evidence
suggests a potential role for endogenous cytokines, specifically interleukin-1 (IL-1),
interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-alpha) in the development of
depression in the medically ill, including cancer patients. These same cytokines have been
noted to be elevated in pancreas cancer patients. The main goal of this pilot study is to
examine the role of specific endogenous cytokines (IL-1, IL-6, TNF-alpha, as well as IL-10,
Il-15 and IFN-gamma) in the development of Major Depressive Syndrome (MDS) in patients with
pancreatic cancer. To achieve our goal, we will examine the relationships between serum
cytokines (IL-1, IL-6, TNF-alpha, as well as IL-10, Il-15 and IFN-gamma) and clinical
depression (i.e. MDS) utilizing a cross sectional design in 4 samples of patients: a)
Pancreas cancer patients with a DSM-IV diagnosis of MDS (N=25); b) Pancreas cancer patients
without a DSM-IV diagnosis of MDS (N=25); c) Healthy Controls with a DSM-IV diagnosis of MDS
(N=25); and d) Healthy Controls without a DSM-IV diagnosis of MDS (N=25). Measures will
include a structural clinical interview for DSM-IV diagnosis (SCID) of Major Depressive
Syndrome, as well as measures of depressive symptom severity, fatigue severity,
concentration and attention, and cognitive function. Plasma concentrations of endogenous
cytokines ((IL-1, IL-6, TNF-alpha, as well as IL-10, Il-15 and IFN-gamma) will be measured
utilizing standard assays. Our specific aims are: 1) To preliminarily examine the
relationships between plasma concentrations of endogenous cytokines (IL-1, Il-6, TNF-alpha,
as well as IL-10, Il-15 and IFNgamma) and a DSM-IV diagnosis of Major Depressive Syndrome in
patients with pancreas cancer and healthy controls; 2) To explore the relationships between
plasma concentrations of endogenous cytokines (Il-1, Il-6, TNF-alpha, as well as IL-10,
Il-15 and IFN-gamma) and the phenomenology and severity of depressive symptoms, presence and
severity of fatigue, and degree of impairment in attention, concentration and cognition, in
depressed patients with pancreas cancer and healthy depressed controls. The results of this
pilot study will be utilized to seek NIH funding for larger, longitudinal,
multi-institutional, studies examining the role of endogenous cytokines in pancreas cancer
patients, as well as clinical intervention trials for the treatment of clinical depression
in pancreas cancer patients that utilize specific cytokine antagonists as adjuncts to
antidepressant drug therapies.


Inclusion Criteria:



1. 40 years of age or older at the time of recruitment.

2. Unresectable/inoperable pancreatic adenocarcinoma (stage III or IV), receiving
Gemcitabine or Gemcitabine-based combination therapy.

3. If in the "depressed" sample, patients with pancreatic cancer must meet DSM-IV
criteria for a major depressive syndrome (based on the SCID) AND have an HDRS score
of 18 or greater.

4. If in the "non-depressed" sample, patients with pancreatic cancer must not meet
DSM-IV criteria for a major depressive syndrome (based on the SCID) AND must have a
HDRS score of 17 or less.

Exclusion Criteria:

1. A. Patient has reported experiencing or medical record indicates a serious medical
event (i.e.,medical hospitalization (excluding hospitalization related to cancer
diagnosis/treatment),myocardial infarction, stroke) within the year preceding study
participation.

B. Patient has reported the presence of or medical record indicates:

- Type 1 Diabetes, unrelated to cancer diagnosis

- renal failure requiring dialysis

- inflammatory bowel disease 3. Patient has reported the presence of or medical record
indicates an active secondary cancer diagnosis, however patients who have been
treated for a past cancer and are 2 years disease free from that cancer can
participate.

4. Presence of a medical/surgical condition obtained through self-report associated
with elevated cytokine levels, such as:

- HIV/AIDS

- Auto-immune diseases such as SLE, Multiple Sclerosis, Rheumatoid Arthritis,
Polymyalgia Rheumatica, Temporal Arteritis, Chronic Fatigue Syndrome, severe
allergies

- Congestive Heart Failure

- Recent stroke

- Alzheimer's Disease

- Active infection;

- Acute pancreatitis

- Acute pericarditis

- Acute hepatitis including Hepatitis C

- Recent vaccination for viral disease

- Major surgery within the past 6 weeks

5. Patient Reports Receiving treatment (within two weeks) with:

- Interleukin

- Interferon

- Thalidomide

- NSAID's

- Cox-2 inhibitors

- Cancer vaccine therapies

6. Self-reported diagnosis with a major psychiatric disorder other than depression
(e.g. psychosis secondary to Bipolar Disorder, Schizophrenia, Schizo-affective
illness, substance abuse) so severe that, in the opinion of the study staff, would
interfere with a patient's ability to give informed consent for research.

7. Cognitive impairment so severe that, in the opinion of the study staff, would
interfere with a patient's ability to give informed consent or complete study
measures for research.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The levels of specific cytokines (IL-1, Il-6, TNF-alpha, as well as IL-10, Il-15 and IFN-gamma), the diagnosis of Depression, depressive symptom severity, and the pattern of depressive symptoms.

Outcome Time Frame:

November 2010

Safety Issue:

No

Principal Investigator

Williams Breitbart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

05-117

NCT ID:

NCT00582699

Start Date:

November 2005

Completion Date:

November 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Pancreatic
  • Depression
  • Depressive Disorder
  • Pancreatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021