Depression, Cytokines and Pancreatic Cancer
April 9, 2014 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Recruitment of patients will take place primarily in the Ambulatory Care Facility on 53rd street in the GI Oncology Clinic treating pancreatic cancer.
Healthy control subjects with depression will be recruited from the New York Hospital Payne Whitney Clinic outpatient facilities and MSKCC. Healthy control subjects without depression will be recruited from contacts supplied by study participants (e.g. spouses, relatives and friends) and from Memorial Hospital staff volunteers.
Description
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:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Patients with pancreatic cancer who meet DSMIV criteria for a current diagnosis of a Major Depressive Episode (N=25).
|
All subjects will be administered a battery of clinician rated and self report instruments including measures of depression, fatigue, and cognitive functioning.
In addition, measures of pain, sleep, and anxiety will also be utilized to assess these important potential confounding variables.
The SCIDIV will be used to ascertain the presence or absence of a current DSMIV diagnosis of Major Depressive Episode for all subjects.
The interview should take approximately fortyfive minutes to complete.
Patients will have their blood drawn once, in order to determine plasma levels of the cytokines IL1, IL6, TNFalpha, IL10, IL15 and IFNgamma.
|
|
2
Patients with pancreatic cancer who do not meet DSMIV criteria for a current diagnosis of Major Depressive Episode (N=25)
|
All subjects will be administered a battery of clinician rated and self report instruments including measures of depression, fatigue, and cognitive functioning.
In addition, measures of pain, sleep, and anxiety will also be utilized to assess these important potential confounding variables.
The SCIDIV will be used to ascertain the presence or absence of a current DSMIV diagnosis of Major Depressive Episode for all subjects.
The interview should take approximately fortyfive minutes to complete.
Patients will have their blood drawn once, in order to determine plasma levels of the cytokines IL1, IL6, TNFalpha, IL10, IL15 and IFNgamma.
|
|
3
Healthy controls who meet DSMIV criteria for a current diagnosis of Major Depressive Episode (N=25).
|
All subjects will be administered a battery of clinician rated and self report instruments including measures of depression, fatigue, and cognitive functioning.
In addition, measures of pain, sleep, and anxiety will also be utilized to assess these important potential confounding variables.
The SCIDIV will be used to ascertain the presence or absence of a current DSMIV diagnosis of Major Depressive Episode for all subjects.
The interview should take approximately fortyfive minutes to complete.
Patients will have their blood drawn once, in order to determine plasma levels of the cytokines IL1, IL6, TNFalpha, IL10, IL15 and IFNgamma.
|
|
4
Healthy controls who do not meet DSMIV criteria for a current diagnosis of Major Depressive Episode (N=25).
|
All subjects will be administered a battery of clinician rated and self report instruments including measures of depression, fatigue, and cognitive functioning.
In addition, measures of pain, sleep, and anxiety will also be utilized to assess these important potential confounding variables.
The SCIDIV will be used to ascertain the presence or absence of a current DSMIV diagnosis of Major Depressive Episode for all subjects.
The interview should take approximately fortyfive minutes to complete.
Patients will have their blood drawn once, in order to determine plasma levels of the cytokines IL1, IL6, TNFalpha, IL10, IL15 and IFNgamma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: November 2010
|
November 2010
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Williams Breitbart, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Estimate)
April 10, 2014
Last Update Submitted That Met QC Criteria
April 9, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-117
- NIH CA102201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.