Depression, Cytokines and Pancreatic Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Pancreatic Cancer

Treatments

Behavioral: assessment interview and blood draw

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00582699

05-117

NIH CA102201

Details and patient eligibility

About

The purpose of this study is to measure certain specific chemicals in your blood, produced by the body in response to a stress, such as having pancreatic cancer. These chemicals are called "cytokines" and the researchers doing this study want to look at the role they may play in developing depression.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

40 years of age or older at the time of recruitment.
Unresectable/inoperable pancreatic adenocarcinoma (stage III or IV), receiving Gemcitabine or Gemcitabine-based combination therapy.
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.
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

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.
1. 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
1. Patient Reports Receiving treatment (within two weeks) with:
Interleukin
Interferon
Thalidomide
NSAID's
Cox-2 inhibitors
Cancer vaccine therapies
1. 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.
2. 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.