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.