Status:
TERMINATED
Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Pancreatic Ductal Adenocarcinoma
Periampullary Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Use of antidepressants for participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy.
Detailed Description
Anti-depressants have been shown to be beneficial in cancer participants. They reduce depressive symptoms and improve quality of life. Randomized trials have shown that antidepressants can reduce the ...
Eligibility Criteria
Inclusion
- Subjects must have histologically or cytologically confirmed localized or locally advanced pancreatic ductal adenocarcinoma or other periampullary adenocarcinoma (bile duct, duodenal, ampullary)
- Subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine
- Aged 18-80 years.
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2
- Planned to have at least 12 weeks of neoadjuvant chemotherapy as standard of care cancer treatment
- No diagnosis of bipolar disease
- Willing to comply with all study procedures and be available for the duration of the study
- Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients under the age of 18 or over 80
- Metastatic pancreatic or other periampullary cancer
- Resection of pancreatic cancer within the past year prior to study enrollment or planned surgery within the next 12 weeks.
- Currently on an antidepressant, anti-anxiety, anti-bipolar or anti-psychotic medicine. Patients who have taken MAOIs (Monoamine Oxidase Inhibitors) within the past 6 months are excluded.
- Patients with a history of seizure disorder
- Patients with a recent medical history of myocardial infarction or unstable heart disease
- Patients with a history of QTc prolongation or torsade de points, a baseline QTc
- interval of \> 500ms, a history of drug-induced QTc prolongation or congenital long QT
- syndrome
- Patients with Child-Pugh score of B or C
- Patients with moderate to severe renal disease with a GFR (glomerular filtration rate) \< 45.
- Patients who cannot ingest oral medication
- Patients with any history of mania
- Known allergy to escitalopram
- Pregnancy or lactation
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05289830
Start Date
August 5 2022
End Date
August 27 2023
Last Update
December 10 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106