Symptom Management Trial in Cancer Survivors
35 Years
85 Years
Both
Colorectal Cancer, Depression, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Fatigue, Gallbladder Cancer, Gastric Cancer, Liver Cancer, Lung Cancer, Pancreatic Cancer
Trial Information
Symptom Management Trial in Cancer Survivors
OBJECTIVES:
- Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive
disorder in patients with advanced lung or gastrointestinal cancer.
- Compare the side effect burden of escitalopram oxalate vs placebo in these patients.
- Determine potential moderators of the efficacy of escitalopram oxalate in these
patients, including medical, psychological, and social variables.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to stage of disease (stage IIIB with effusions vs stage IV) and current
treatment (radiation vs chemotherapy vs novel agent). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive oral placebo once daily for 4 weeks followed by oral placebo
once daily for another 4 weeks
- Arm II: Patients receive oral placebo once daily for 4 weeks followed by escitalopram
oxalate 10 mg once daily for 4 weeks.
- Arm III: Patients receive oral escitalopram oxalate 10 mg once daily for 4 weeks
followed by oral placebo once daily for 4 weeks.
After 8 weeks, all non-responders are offered open treatment with an antidepressant.
Depression, fatigue, quality of life, anxiety, and somatization are assessed at baseline and
then at 4 and 8 weeks.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of any of the following for at least 4 weeks:
- Stage IIIB (with effusions) or stage IV non-small cell lung cancer
- Extensive stage small cell lung cancer
- Stage III or IV pancreatic cancer
- Stage IV liver cancer
- Stage III or IV gallbladder cancer
- Stage III or IV bile duct cancer
- Stage IV esophageal cancer
- Stage IV gastric cancer
- Second line stage IV colorectal cancer
- Meets diagnostic and Statistical Manual of Mental Disorders-4th Edition and Endicott
criteria for major depressive disorder
- Duration of depressive symptoms ≥ 4 weeks
- Hamilton Depression D 17 (HAM-D 17) Scale ≥ 14
- No active suicidality requiring immediate care or psychiatric hospitalization
PATIENT CHARACTERISTICS:
- Able to swallow pills
- No active substance abuse disorder (including alcohol abuse within the past 6
months), psychotic disorder or active psychotic symptoms, organic mental disorders,
or bipolar disorder
- No clinical or laboratory evidence of hypothyroidism
- No hypercalcemia
- No severe anemia, defined as hemoglobin < 10 g/dL
- No history of multiple adverse drug reactions or allergy to study drugs
- Not pregnant
- No history of head trauma
- No history of epilepsy
PRIOR CONCURRENT THERAPY:
- No other concurrent antidepressant medications or psychostimulants
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
Outcome Description:
Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
William F. Pirl, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000505774
NCT ID:
NCT00387348
Start Date:
March 2006
Completion Date:
April 2011
Related Keywords:
- Colorectal Cancer
- Depression
- Esophageal Cancer
- Extrahepatic Bile Duct Cancer
- Fatigue
- Gallbladder Cancer
- Gastric Cancer
- Liver Cancer
- Lung Cancer
- Pancreatic Cancer
- fatigue
- psychosocial effects of cancer and its treatment
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- extensive stage small cell lung cancer
- advanced adult primary liver cancer
- depression
- stage III pancreatic cancer
- stage IV pancreatic cancer
- stage IV esophageal cancer
- stage IV gastric cancer
- stage IVA colon cancer
- stage IVB colon cancer
- stage IVA rectal cancer
- stage IVB rectal cancer
- unresectable gallbladder cancer
- unresectable extrahepatic bile duct cancer
- Colorectal Neoplasms
- Depression
- Depressive Disorder
- Esophageal Diseases
- Esophageal Neoplasms
- Fatigue
- Liver Neoplasms
- Lung Neoplasms
- Stomach Neoplasms
- Pancreatic Neoplasms
- Gallbladder Neoplasms
- Bile Duct Neoplasms
- Gastrointestinal Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
