Clinical trial NCT05289830: Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
Official title: A Phase II, Randomized, Double-blind, Trial Comparing Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Ductal Adenocarcinoma
Periampullary Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 development of depression in non-depressed participants with breast, melanoma, and head and neck cancers. It has been shown that treating depression can impact survival in cancer participants. Additionally, depressed pancreatic cancer participants have worse survival. Therefore, anti-depressants may also have implications for cancer treatment.

Eligibility criteria: Inclusion Criteria:

1. Subjects must have histologically or cytologically confirmed localized or locally advanced pancreatic ductal adenocarcinoma or other periampullary adenocarcinoma (bile duct, duodenal, ampullary)
2. Subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine
3. Aged 18-80 years.
4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2
5. Planned to have at least 12 weeks of neoadjuvant chemotherapy as standard of care cancer treatment
6. No diagnosis of bipolar disease
7. Willing to comply with all study procedures and be available for the duration of the study
8. Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients under the age of 18 or over 80
2. Metastatic pancreatic or other periampullary cancer
3. Resection of pancreatic cancer within the past year prior to study enrollment or planned surgery within the next 12 weeks.
4. 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.
5. Patients with a history of seizure disorder
6. Patients with a recent medical history of myocardial infarction or unstable heart disease
7. Patients with a history of QTc prolongation or torsade de points, a baseline QTc

   1. interval of \> 500ms, a history of drug-induced QTc prolongation or congenital long QT
   2. syndrome
8. Patients with Child-Pugh score of B or C
9. Patients with moderate to severe renal disease with a GFR (glomerular filtration rate) \< 45.
10. Patients who cannot ingest oral medication
11. Patients with any history of mania
12. Known allergy to escitalopram
13. Pregnancy or lactation

Primary outcomes:
measure: Change in the rate of depression
timeFrame: 12 weeks from the start of treatment
Secondary outcomes:
measure: Quality of Life using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) survey
timeFrame: Up to 3 years from the treatment date
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Jordan Winter, MD
role: PRINCIPAL_INVESTIGATOR
References: